Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

Start Date31 Dec 2025

Sponsor / Collaborator

The Holden Comprehensive Cancer Center

NCT05314998 / Not yet recruitingPhase 3IIT

An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Start Date15 Jan 2025

Sponsor / Collaborator

Heidelberg University, U.S.

[+3]

NCT06719479 / Not yet recruitingPhase 2/3

A Phase II/III Clinical Trial to Evaluate the Effect of IAE0972 Combined with Chemotherapy Selected by Doctors for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma/Nasopharyngeal Carcinoma.

Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R/M HNSCC/NPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy.
Phase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R/M NPC who failed or progressed after treatment with ≤2-line system.

Start Date01 Jan 2025

Sponsor / Collaborator

Sunho (China) Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

439

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Nov 2024·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Synergistic effect of Gemcitabin-loaded metal organic frameworks nanoparticles with particle therapy

Article

Author: Schanne-Klein, Marie-Claire ; Mahou, Pierre ; Porcel, Erika ; Maury, Pauline ; Li, Xue ; Gref, Ruxandra ; Hirayama, Ryoichi ; Lacombe, Sandrine

Combination of nanoagents with radiations has opened up new perspectives in cancer treatment, improving both tumor diagnosis and therapeutic index. This work presents the first investigation of an innovative strategy that combines porous metal-organic frameworks (nanoMOFs) loaded with the anti-cancer drug Gemcitabine monophosphate (GemMP) and particle therapy-a globally emerging technique that offers more precise radiation targeting and enhanced biological efficacy compared to conventional radiotherapy. This radiochemotherapy has been confronted with two major obstacles limiting the efficacy of therapeutics when tested in vivo: (i) the presence of hypoxia, one of the most important causes for radiotherapy failure and (ii) the presence of a microenvironment, main biological barrier to the direct penetration of nanoparticles into cancer cells. On the one hand, this study explore the effects of hypoxia on drug delivery systems in combination with radiation, demonstrating that GemMP-loaded nanoMOFs significantly enhance the anticancer efficacy of particle therapy under both normoxic (pO₂ = 20 %) and hypoxic (pO₂ = 0.5 %) conditions. Notably, the presence of GemMP-loaded nanoMOFs allows the irradiation dose to be reduced by 1.4-fold in normoxia and at least 1.6-fold in hypoxia, achieving the same cytotoxic effect (SF=10 %) as carbon or helium ions alone. Synergistic effects between GemMP-loaded nanoMOFs and radiations have been observed and quantified. On the other hand, we also highlighted the ability of the nanoMOFs to diffuse through an extracellular matrix and accumulate in cells. An higher effect of the encapsulated GemMP than the free drug was observed, confirming the key role of the nanoMOFs in transporting the active substance to the cancer cells as a Trojan horse. This paves the way to the design of "all-in-one" nanodrugs where each component plays a role in the optimization of cancer therapy to maximize cytotoxic effects on hypoxic tumor cells while minimizing toxicity on healthy tissue.

01 Oct 2024·European urology oncology

Radiotherapy Combined with a Radiosensitizer for Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Carcinoma In Situ Bladder Cancer: An Open-label, Single-arm, Multicenter, Phase 2 European Organisation for Research and Treatment of Cancer Trial

Article

Author: Sargos, Paul ; Dirix, Piet ; Tombal, Bertrand ; Roupret, Morgan ; D'Haese, David ; Fournier, Béatrice ; Krzystyniak, Joanna ; Achard, Vérane

Radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of care for patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). However, many patients are unwilling or unable to undergo such major surgery associated with high morbidity and a negative impact on quality of life. Chemoradiotherapy is an established treatment option for muscle-invasive bladder cancer. However, it has not been investigated adequately in NMIBC until now. The European Organisation for Research and Treatment of Cancer (EORTC) 2235 study (NCT06310369) is designed as a multicenter, prospective, international, phase 2 trial of moderate hypofractionated radiotherapy combined with a radiosensitizer in BCG-unresponsive NMIBC patients with carcinoma in situ (CIS) who are not eligible for or declined to undergo radical cystectomy. Patients who have received nadofaragene firadenovec or TAR-200 are eligible. The primary endpoint is the 6-mo complete response (CR) rate defined by the absence of CIS proven by a control biopsy of the bladder. The secondary endpoints include overall survival, progression-free survival, durability of CR, grade 3-4 adverse events rate, patients' quality of life, and organ preservation rate. PATIENT SUMMARY: Intravesical instillation of bacillus Calmette-Guérin is the standard treatment of non-muscle-invasive, also coined as superficial, bladder cancer. In case the cancer recurs, even superficially, there is no other proven treatment than a radical cystectomy-the surgical removal of the bladder. Although the surgical technique has improved dramatically over the past few years, it remains contraindicated in patients with severe comorbidities. In addition, because it affects the quality of life, patients may reject this option. This study will assess the efficacy of external beam radiotherapy, a robust alternative to surgery in muscle-invasive bladder cancer. Radiotherapy will be administered 5 d a week for 4 wk. It will be associated with a "radiosensitizer," an intravenous or oral drug, during the radiotherapy treatment. The study will measure the proportion of patients remaining recurrence free at 6 mo and thereafter. It will also evaluate the safety of the treatment and its impact on quality of life.

01 Apr 2024·European urology open science

The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association–defined Intermediate-risk Non–muscle-invasive Bladder Cancer Patients: A Phase 1b Study

Article

Author: Kelley, April ; Stromberg, Katharine A ; Steenbruggen, Jessica J O ; Somford, Diederik M ; van der Heijden, Antoine G ; Chau, Albert ; Keegan, Kirk A ; Bhanvadia, Sumeet ; Jin, Shu ; P van Valenberg, F Johannes ; Alfred Witjes, J ; Cutie, Christopher J ; Li, Xiang ; Iarossi, Crysti ; Hampras, Shalaka ; Sweiti, Hussein ; Maffeo, John C ; Reynolds, Donald L ; Michiel Sedelaar, J P

Background and objective:

Patients with intermediate-risk non-muscle-invasive bladder cancer (IR NMIBC) have a high risk of recurrence and need effective therapies to reduce the risk of disease recurrence or progression. This phase 1b study (NCT02720367) assessed the safety and tolerability of TAR-200, an intravesical drug delivery system, in participants with IR NMIBC.

Methods:

Participants with recurrent IR NMIBC were eligible. Participants received either two 7-d or two 21-d TAR-200 dosing cycles over a 4-6-wk period in a marker lesion/ablation design. TAR-200 was placed in the window between the cystoscopy showing recurrent papillary disease and the subsequent complete transurethral resection of the bladder tumour. The primary endpoint was TAR-200 safety. The secondary endpoints included TAR-200 tolerability, pharmacokinetics, and preliminary efficacy.

Key findings and limitations:

Twelve participants received TAR-200 treatment. No TAR-200-related serious or grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred. Nine participants had grade ≤ 2 TAR-200-related TEAEs, with urgency, dysuria, and haematuria being most common. Two participants refused a second dosing cycle due to urinary urgency and frequency. Insertion and removal of TAR-200 was successful in all cases. Plasma gemcitabine concentrations remained below the lower limit of detection. Five participants (42%) had complete response (CR): four had pathological CR and one had CR based on visual assessment.

Conclusions and clinical implications:

TAR-200 appears to be safe and well tolerated, with encouraging preliminary efficacy in participants with IR NMIBC. This study lays the groundwork for the multiple phase 2 and 3 global studies that are currently on-going for TAR-200.

Patient summary:

In this study, researchers evaluated the safety of the novel drug delivery system TAR-200 in participants with intermediate-risk non-muscle-invasive bladder cancer. They concluded that TAR-200 was safe and well tolerated with promising antitumour activity.

178

News (Medical) associated with Gemcitabine Hydrochloride

03 Dec 2024

·www.businesswire.com

Ferring Advances Three Studies in ADSTILADRIN® (nadofaragene firadenovec-vncg) Clinical Trial Program

PARSIPPANY, N.J.--( BUSINESS WIRE )--Ferring Pharmaceuticals today announced it has advanced three studies in the ADSTILADRIN ® (nadofaragene firadenovec-vncg) clinical trial program – two studies in patients with non-muscle invasive bladder cancer (NMIBC), and one study in patients with upper tract urothelial cancer (UTUC). The Company also announced researchers will present at the 25 th Annual Meeting of the Society of Urologic Oncology (SUO) the study protocol for patients with intermediate-risk NMIBC and additional data from a Phase 3, open-label study demonstrating clinically meaningful cystectomy-free survival (CFS) after five years among patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC who achieved an initial complete response at three months with ADSTILADRIN. ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) in patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). Study sites in the U.S. were activated for two studies in the ABLE ( A DSTILADRIN in BL adder Canc E r) clinical trial program in NMIBC: The three-arm, Phase 2 ABLE-22 ( NCT06545955 ) trial is assessing the efficacy and safety of ADSTILADRIN as a monotherapy and as part of combination with chemotherapy or an immune checkpoint inhibitor for high-risk BCG-unresponsive NMIBC. Investigators in all three arms of the ABLE-22 study will have the option to re-induce appropriate patients who do not achieve a complete response to the initial single dose or combination regimen, an option that was not included in the original Phase 3 study. The Phase 3B ABLE-32 ( NCT06510374 ) trial is assessing the efficacy and safety of ADSTILADRIN in intermediate-risk NMIBC (IR NMIBC), for which there are no U.S. FDA-approved treatment options. Ferring also initiated the LUNAR ( L ow-Grade U TUC Treated with N adofaragene firadenovec A dministered to R enal Pelvis) study ( NCT06668493 ), a Phase 1-2, multi-center, multi-national, open-label, single-arm, repeat dose clinical trial evaluating the safety, tolerability, and efficacy of ADSTILADRIN instilled to the renal pelvis in patients with low-grade UTUC (LG UTUC). “The availability of an innovative locally delivered gene therapy has the potential to be organ sparing for appropriate NMIBC and UTUC patients. The extension of the ADSTILADRIN clinical trial program – with a focus on IR NMIBC and LG UTUC where there is a desperate need for new treatments, and generation of mono and combination therapy data, including re-induction, for high-risk BCG-unresponsive NMIBC – is key to understanding how ADSTILADRIN may be able to help even more patients,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “We are pleased to have these studies underway to build on the evidence reported in the original Phase 3 study. Formalizing the collection of re-induction data in patients who do not achieve a complete response at their first three-month assessment also will add to our pursuit of strategies to potentially offer more patients the opportunity to preserve their bladder and avoid radical surgery.” About ADSTILADRIN Poster Presentations at SUO ADSTILADRIN poster titles and presentation times at the SUO 2024 Annual Meeting, December 4-6, are: Incidence and Pathologic Outcomes of Cystectomy in Patients With Bacillus Calmette-Guérin-Unresponsive Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ Following Treatment With Nadofaragene Firadenovec-vncg, Poster #215, Friday, December 6 from 10:00-11:00 a.m. CST ABLE-32: A Randomized, Controlled, Phase 3B Clinical Trial of Nadofaragene Firadenovec-vncg Versus Observation in Patients With Intermediate-Risk Non–Muscle-Invasive Bladder Cancer, Poster #232, Friday, December 6 from 1:45-2:45 p.m. CST About the ADSTILADRIN Clinical Trial Program Results from the final analysis of the 60-month follow-up data from the pivotal ADSTILADRIN Phase 3 clinical trial were announced earlier this year. Re-induction in patients who did not achieve a complete response at three months after a single initial dose was not included in the protocol. 1 “The original Phase 3 study design was purposefully conservative and only allowed patients who demonstrated a complete response at three months to continue quarterly treatment with ADSTILADRIN as investigators confirmed the overall safety with low risk of progression of gene therapy in this patient population,” said Colin P.N. Dinney, M.D., Chairman of the Department of Urology, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, and a lead investigator of the Phase 3 study. “The ADSTILADRIN Phase 3 clinical trial transformed our understanding of the treatment of patients with BCG-unresponsive NMIBC and paved the way to allow re-induction in subsequent studies.” Earlier this quarter, Ferring decided to prioritize collection of ADSTILADRIN re-induction data in patients with high-risk BCG-unresponsive NMIBC who did not have a complete response to the initial single dose of ADSTILADRIN through data sources within the clinical setting, including ABLE-22 and ABLE-41 ( NCT06026332 ), and discontinued the previously announced ABLE-42 clinical trial. The ABLE-41 study – currently enrolling patients – is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting in high-risk BCG-unresponsive NMIBC patients. “The approval of ADSTILADRIN and its successful launch has transformed the treatment landscape for BCG-unresponsive NMIBC patients, offering them new hope for durable bladder preservation. We hope to see efficacy together with the same low treatment burden and manageable safety profile for ADSTILADRIN in IR NMIBC and as part of combination therapy in BCG-unresponsive NMIBC,” said Bipin Dalmia, Global Head of Uro-Oncology & Urology Franchise, Ferring Pharmaceuticals. “Expanding our program within NMIBC and also to UTUC with the LUNAR study is another step forward in our leadership journey to establish ADSTILADRIN as the new standard of care and the backbone therapy for patients across the urothelial cancer disease spectrum.” About the ABLE and LUNAR Clinical Trials ABLE-22 is a Phase 2, randomized, multi-center, open-label three-arm trial evaluating the efficacy and safety of ADSTILADRIN as a monotherapy or in combination with chemotherapy (gemcitabine and docetaxel) or an immune checkpoint inhibitor (pembrolizumab) in adult patients with high-grade BCG-unresponsive NMIBC. High-grade tumors are more likely to grow and spread quickly. The study’s primary endpoint is a complete response (defined as absence of low- and high-grade disease) at month 3 (or month 6 for re-induced patients). Appropriate patients in all three treatment arms of ABLE-22 who do not have a complete response to the first three-month assessment will have the potential to receive re-induction with a second quarterly dose of ADSTILADRIN. ABLE-32 is a Phase 3B, randomized, controlled trial assessing the potential efficacy and safety of ADSTILADRIN in patients with IR NMIBC. More than 450 participants from 100 global sites are expected to be enrolled and will either receive quarterly doses of ADSTILADRIN or undergo continued observation following transurethral resection of bladder tumor (TURBT) within 60 days prior to randomization. The primary efficacy endpoint is recurrence-free survival (RFS), from baseline to first documented recurrence, progression, or death, whichever occurs first during the treatment period. ABLE-41 is an ongoing, multi-center, non-interventional, real-world evidence (RWE) study following patients with NMIBC aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. The study is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting, including re-induction with a second quarterly dose in patients without a complete response to the initial single dose. The first patient was enrolled in September 2023. LUNAR is a Phase 1-2 single-arm, open label trial evaluating the safety, tolerability, and efficacy of ADSTILADRIN in patients with low-grade UTUC. A safety lead-in period will be conducted for the first six patients. Absence of UTUC in the renal pelvis at months 3 or 6 will be defined as a complete response. Duration of response up to month 30 will be defined as the time from first achieved complete response to disease recurrence, progression to high-grade disease or disease-specific death, whichever occurs first. About ADSTILADRIN ADSTILADRIN ® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer. ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 ). 2 Ferring is leading the future in uro-oncology treatment with ADSTILADRIN at the center, while expanding access with the support of new, state-of-the-art manufacturing facilities. As announced in January 2024, ADSTILADRIN is fully available and accessible in the U.S. ADSTILADRIN has confirmed 99 percent coverage for commercial and government-insured patients. As of April 1, 2024, in accordance with the Centers for Medicare and Medicaid Services (CMS), ADSTILADRIN established an Average Sales Price (ASP). Since the establishment of ASP, all covered claims submitted for reimbursement have received payment within an average of 25 days. 3 Ferring is committed to investing in novel therapies, developing life-changing solutions that address unmet medical needs, and aiding the uro-oncology community in helping patients live better lives. More information is available in the U.S. at the dedicated Ferring Uro-Oncology channel on LinkedIn . About Non-Muscle Invasive Bladder Cancer (NMIBC) NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall. 4 In the United States, bladder cancer is the sixth most common cancer, 5 fourth among men, 6 and it is estimated that there will be approximately 83,190 new cases of bladder cancer in the U.S. in 2024. 6 Historically, 75% of bladder cancer presents as NMIBC. 7 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease. 8 Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder). 9 About Low-Grade Upper Tract Urothelial Cancer (UTUC) UTUC accounts for about 10 percent of all urothelial cancers - cancer of the lining within the kidneys, bladder, or ureters – with the majority occurring in the lower tract or bladder. 10 Clinicians use several standardized assessment and clinical staging methods to risk-stratify patients into “low” or “high” risk for progression to identify patients who are most likely to benefit from kidney-sparing treatment. 10 Tumors that block the ureter or kidney can cause hydronephrosis (swelling of the kidney), infections, and impairment of kidney function. 10 Low-grade tumors comprise all low-risk and some high-risk tumors in UTUC with management goals including treatment of visible tumors and preservation of the urinary tract. 10 There is an estimated total incidence of just over 7,000 new UTUC cases each year in the U.S., 10 and the prevalence appears to be increasing. 11 INDICATION ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product. WARNINGS AND PRECAUTIONS: Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy. Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration. USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose. ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING. Please click to see the full Prescribing Information . About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit www.ferringusa.com , call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn , and X (Twitter) . References: Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of Intravesical Nadofaragene Firadenovec for Patients with Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer: 5-year Follow-up from a Phase 3 Trial. J Urol. 2024;212(1):74-86. doi:10.1097/JU.0000000000004020. ADSTILADRIN in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. Available at: https://clinicaltrials.gov/ct2/show/NCT02773849 . Accessed November 5, 2024. Ferring Access Support benefits investigations for commercial and government-insured patients through March 15, 2024. Urology Care Foundation. Non-muscle Invasive Bladder Cancer: Symptoms, Diagnosis & Treatment. Available at: https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer . Accessed November 5, 2024. National Cancer Institute. Cancer Statistics. Available at: https://www.cancer.gov/about-cancer/understanding/statistics#:~:text=The%20most%20common%20cancers%20%28listed%20in%20descending%20order,pancreatic%20cancer%2C%20leukemia%2C%20thyroid%20cancer%2C%20and%20liver%20cancer . Accessed November 5, 2024. American Cancer Society. Key Statistics for Bladder Cancer. Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html . Accessed November 5, 2024. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94. Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078. doi: 10.3390/curroncol31020079. National Comprehensive Cancer Network. Bladder Cancer (Version 4.2024). Available at: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf . Accessed November 5, 2024. Coleman JA, Clark PE, Bixler BR, et al. Diagnosis and Management of Non-metastatic Upper Tract Urothelial Carcinoma: AUA/SUO Guideline. J Urol. 2023;209(6):1071-1081. Raman, J and Shore, ND. Management of Low-grade Upper Tract Urothelial Carcinoma: An Unmet Need. Rev Urol. 2020;22(1):1–8.

Phase 3Phase 2Drug ApprovalGene TherapyClinical Result

02 Dec 2024

·www.businesswire.com

Zai Lab and Novocure Announce Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer

SHANGHAI & CAMBRIDGE, Mass. & ROOT, Switzerland--( BUSINESS WIRE )--Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. “As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. “These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.” In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P =0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies. “PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years,” said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure. “We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.” “There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in China, and this cancer is one of the most challenging to treat globally, with limited effective treatment options and poor survival outcomes,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement. We are pleased to have been able to contribute to the PANOVA-3 study, and we look forward to working with Novocure to bring this therapy to patients as soon as possible.” Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Zai Lab plans to file for regulatory approval in China. About PANOVA-3 PANOVA-3 is a prospective, randomized open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months. About Pancreatic Cancer in China Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type 1 . The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2% 2 , making it the malignancy with the lowest survival rate in China. 1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590. 2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321. About Tumor Treating Fields Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com . About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure’s global headquarters is located in Root Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter) . Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov .

Phase 3Clinical Result

02 Dec 2024

·www.businesswire.com

Novocure Announces Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer

ROOT, Switzerland--( BUSINESS WIRE )--Novocure (NASDAQ: NVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. “As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. “These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.” In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P =0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies. “PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years,” said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure. “We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.” Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Novocure continues to follow patients in its Phase 2 PANOVA-4 trial, exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment with data anticipated in 2026. About PANOVA-3 PANOVA-3 is a prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months. About PANOVA-4 PANOVA-4 is an international, multi-center Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treating of metastatic pancreatic cancer. The primary endpoint is disease control rate. Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response and toxicity. The study is designed to enroll 76 patients. About Pancreatic Cancer Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. 1 While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. 2 It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S. 3 Pancreatic cancer has a five-year relative survival rate of just 13%. 4 Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option. About Tumor Treating Fields Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com . About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure’s global headquarters is located in Root Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter) . Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “could” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. 1 American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024. 2 https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC9476884/#B4 3 American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024. 4 American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024.

Phase 3Phase 2Clinical ResultRadiation Therapy

100 Deals associated with Gemcitabine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Lung Non-Small Cell Carcinoma	AU	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	AU	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	AU	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	JP	Eli Lilly & Co.	25 Nov 2008
Biliary Tract Neoplasms	JP	Eli Lilly & Co.	31 Aug 2001
Lymphoma	JP	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	JP	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	US	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	US	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	US	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	US	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	US	Eli Lilly & Co.	15 May 1996

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Bladder Cancer	Phase 3	US	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	CN	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	JP	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	AR	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	BE	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	BR	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	FR	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	DE	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	IT	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	PL	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	fvukvzmayp(ojrndghgsy) = grfxaaejji ijvpittqjd (kpatzubrtg, bzgkmbxzsn - ackabdevdq) View more	-	05 Dec 2024
				Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	fvukvzmayp(ojrndghgsy) = xcoxkwaqol ijvpittqjd (kpatzubrtg, vduealbkus - ykpkyfzhho) View more
NCT02953509 (Pubmed \| Blood Adv) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma	132	Magrolimab plrituximabmab	(avytzpkzvq) = dlfluydvpj fawylwpxot (sclryxziki ) View more	Positive	26 Nov 2024
				Magrolimab plrituximabmabgemcitabinetaboxaliplatinatin	(avytzpkzvq) = bcuiuwmdcq fawylwpxot (sclryxziki ) View more
NCT02641847 (BCTOP-T-A01, Literature) Manual	Phase 3	Triple Negative Breast Cancer	498	docetaxel+doxorubicin or epirubicin+cyclophosphamide+gemcitabine+cisplatin (High risk group A)	isgtjnrpii(ttygufvhyb) = fblvppsxoo cgrbessyjx (ioeaoufpak ) View more	Positive	23 Oct 2024
				docetaxel+doxorubicin or epirubicin+cyclophosphamide (High risk group B)	isgtjnrpii(ttygufvhyb) = fplooxddny cgrbessyjx (ioeaoufpak ) View more
NCT03768414 (SWOG 1815, CTgov)	Phase 3	Unresectable Intrahepatic Cholangiocarcinoma \| Advanced biliary tract cancer \| Gallbladder Neoplasms ... View more	452	Nab-paclitaxel+Gem+Cisplatin (Gem+Cisplatin+Nab-paclitaxel)	itaujljzzw(plpabckskh) = hpwfnplulj uenwfwqixh (wwemqbxfdv, xnsaszfkhi - dzzjwqwccx) View more	-	22 Oct 2024
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	itaujljzzw(plpabckskh) = zgdykgrrmy uenwfwqixh (wwemqbxfdv, lvqncwrjxq - cfjhgqmlni) View more
NCT04640623 (SunRISe-1, ESMO2024) Manual	Phase 2	Non-Muscle Invasive Bladder Neoplasms PD-L1 Expression	21	TAR-200 alone	rtfmtbtsfu(ahjirdszds) = fmkflwqose ldzkzmdavg (bmffwhztcd, 58.7 - 99.8)	Positive	15 Sep 2024
				TAR-200 (PD-L1 CPS<10)	rtfmtbtsfu(ahjirdszds) = vqxcrnthis ldzkzmdavg (bmffwhztcd, 34.8 - 93.3)
NCT02769832 (Pubmed \| Front Oncol) Manual	Phase 2	Small Cell Lung Cancer	32	Gemcitabine nab-paclitaxelaxel	(aniyyksmcl) = wlnambbicm zkzrsorfen (rfccvnampi, 15.5 - 100) View more	Positive	31 Jul 2024
NCT01625260 (CTgov)	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	12	Gemcitabine+ALT-801 (0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	umgyxaboet(lobzuntxby) = zwqikqulrc vjhmbctzlo (hnlyfaozmb, exsbpuwnyj - ufkkowiqrj) View more	-	19 Jul 2024
				Gemcitabine+ALT-801 (0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	umgyxaboet(lobzuntxby) = wvhnncjhbi vjhmbctzlo (hnlyfaozmb, mgzbryqvsc - synqereqcq) View more
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	Phase 2	Secondary malignant neoplasm of pancreas	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	ubmzrpodam(jacwglthxp) = kvjltvncmw dqcjtiayck (twrhfgcmtb, byyyyxgnid - rpremtlrst) View more	-	10 Jul 2024
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	ubmzrpodam(jacwglthxp) = mocwrkddec dqcjtiayck (twrhfgcmtb, bzuuealmmj - sclsbdrdhe) View more
NCT03558087 (HCRN GU 16-257, CTgov)	Phase 2	Muscle Invasive Bladder Carcinoma	76	Nivolumab+Gemcitabine+Cisplatin	tstmdmxevm(iubnavtdqk) = jameepxyxm hbwkltjafr (ovyprgilxc, ujgxnymwmq - wfzpvinjrq) View more	-	27 Jun 2024
DDW2024	Not Applicable	Pancreatic Ductal Adenocarcinoma Adjuvant	-	Gemcitabine + Antibiotics	lgwsicdhlh(lvthlphszu) = ifeqagsnxg xzudqprefm (aksummvtcz, 19.7 - 25.9)	Positive	21 May 2024
				Gemcitabine	lgwsicdhlh(lvthlphszu) = mbdmsaehza xzudqprefm (aksummvtcz, 19.5–22.0)

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