Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

Start Date17 Oct 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06393751

/ Not yet recruitingPhase 1/2IIT

A Randomized Phase 1/2 Trial Evaluating the Addition of Tolinapant to Weekly Paclitaxel With or Without Bevacizumab in Patients With Recurrent Epithelial Ovarian Cancer

This phase I/II trial tests the safety, best dose and effectiveness of adding tolinapant (ASTX660) to paclitaxel with or without bevacizumab in treating patients with ovarian cancer that has come back after a period of improvement (recurrent). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, that promote the growth of tumor cells and increase resistance to chemotherapy. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of tumor cells. Adding ASTX660 to paclitaxel with or without bevacizumab may be safe, tolerable and/or effective in treating patients with recurrent ovarian cancer.

Start Date02 May 2025

Sponsor / Collaborator

National Cancer Institute

NCT05312372

/ WithdrawnPhase 1/2IIT

A Phase 1/2, Open -Label, Multicenter Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antineoplastic Activity of S095033 (MAT2A Inhibitor) in Combination With Paclitaxel in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

The purpose of this study is to determinate the safety profile, tolerability, pharmacokinetics, and preliminary antineoplastic activity of S095033 in combination with paclitaxel in participants with advanced or metastatic esophageal squamous cell carcinoma (ESCC)

Start Date01 May 2025

Sponsor / Collaborator

Institut de Recherches Intern Servier

[+1]

100 Clinical Results associated with Paclitaxel

100 Translational Medicine associated with Paclitaxel

100 Patents (Medical) associated with Paclitaxel

40,335

Literatures (Medical) associated with Paclitaxel

01 Dec 2025·Journal of Gastrointestinal Cancer

Network Meta-analysis of Randomized Controlled Trials in Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: Comparisons Involving Ramucirumab

Review

Author: Taipale, Kaisa ; Paine, Abby ; Gupta, Palvi ; D'yachkova, Yulia ; Liepa, Astra M ; Earley-Valovic, Veronika ; Goel, Rajat

PURPOSE:

With relatively few direct comparisons among treatment options for previously treated advanced gastric cancer or gastroesophageal junction (GEJ) cancer, network meta-analysis (NMA) may inform evidence-based decision-making. Ramucirumab plus paclitaxel (RAM + PTX) is a preferred regimen in guideline recommendations. NMA of key outcomes may further characterize the relative clinical value of RAM + PTX.

METHODS:

A systematic literature review of randomized controlled trials of adult patients with previously treated advanced gastric/GEJ cancer informed a NMA which compared overall survival, progression-free survival, and discontinuations due to adverse events. Comparisons were reported relative to placebo/best supportive care (BSC) when possible, otherwise relative to RAM + PTX.

RESULTS:

The base-case NMA focused on second-line treatment only, from 19 of 28 studies identified. For overall survival, seven of 16 regimens were favorable relative to placebo/BSC, with RAM + PTX as the most favorable. For progression-free survival, five of 14 regimens were unfavorable relative to RAM + PTX. For discontinuations due to adverse events, two of 13 regimens were similar to placebo/BSC: ramucirumab monotherapy and fluorouracil; relative to RAM-PTX, all regimens were similar except ramucirumab monotherapy which was favorable and irinotecan + cisplatin which was unfavorable.

CONCLUSION:

This NMA of trials of previously treated gastric/GEJ cancer suggests that RAM + PTX has one of the more favorable clinical profiles.

01 Apr 2025·Cancer Genetics

Prognosis prediction and drug guidance of ovarian serous cystadenocarcinoma through mitochondria gene-based model

Article

Author: Guo, Yi ; Chen, Zhenghu ; Tong, Xiaowen ; Li, Huaifang ; Chen, Meiyi ; Wu, Chenghao ; Zhou, Zixuan ; Shen, Dongsheng

BACKGROUND:

Mitochondrial dysregulation contributes to the chemoresistance of multiple cancer types. Yet, the functions of mitochondrial dysregulation in Ovarian serous cystadenocarcinoma (OSC) remain largely unknown.

AIM:

We sought to investigate the function of mitochondrial dysregulation in OSC from the bioinformatics perspective. We aimed to establish a model for prognosis prediction and chemosensitivity evaluation of the OSC patients by targeting mitochondrial dysregulation.

METHODS:

Differentially expressed genes (DEGs) were screened from the Cancer Genome Atlas (TCGA)-OV dataset and the mitochondrial-related DEGs were identified from the Human MitoCarta 3.0 database. Prognosis-related mitochondria-related genes (MRGs) were screened to establish the MRGs-based risk score model for prognosis prediction. To validate the risk score model, the risk score model was then evaluated by IHC staining intensity and survival curves from clinical specimens of OSC patients. Migration and proliferation assays were performed to elucidate the role of carcinogenic gene ACSS3 in serous ovarian cancer cell lines.

RESULTS:

Using consensus clustering algorithm, we identified 341 MRGs and two subtypes of OSC patients. Moreover, we established a novel prognostic risk score model by combining the transcription level, intensity and extent scores of MRGs for prognosis prediction purpose. The model was established using 7 MRGs (ACOT13, ACSS3, COA6, HINT2, MRPL14, NDUFC2, and NDUFV2) significantly correlated to the prognosis of OSC. Importantly, by performing the drug sensitivity analysis, we found that the OSC patients in the low-risk group were more sensitive to cisplatin, paclitaxel and docetaxel than those in the high-risk group, while the latter ones were more sensitive to VEGFR inhibitor Axitinib and BRAF inhibitors Vemurafenib and SB590885. In addition, patients in the low-risk group were predicted to have better response in anti-PD-1 immunotherapy than those in the high-risk group. The risk score model was then validated by survival curves of high-risk and low-risk groups determined by IHC staining scores of OSC clinical samples. The carcinogenic effect of ACSS3 in OSC was confirmed through the knockdown of ACSS3 in SKOV3 and HO-8910 cells.

CONCLUSION:

To summarize, we established a novel 7 MRGs - based risk score model that could be utilized for prognosis prediction and chemosensitivity assessment in OSC patients.

01 Apr 2025·Non-coding RNA Research

Targeting NUCKS1 with a fragment of tRNAAsn(GUU) of Chinese yew for the treatment of colorectal cancer

Article

Author: Cao, Kai-Yue ; Bai, Long-Bo ; Jiang, Zhi-Hong ; Zhang, Da ; Chen, Yan ; Jiang, Yu-Yang ; Yan, Tong-Meng

Despite the discovery of numerous oncogenes in colorectal cancer (CRC), the development of associated drugs is limited, posing a significant challenge for CRC treatment. Identification of novel druggable targets is therefore crucial for the therapeutic development of CRC. Here, we report the first investigation on therapeutics targeting the potent oncogene NUCKS1 to suppress cancer progression. NUCKS1-orientated bioinformatics screening of NUCKS1 inhibitors from our library of tRNA fragments originated from medicinal plants identified tRF-T36, a 5' tRNA fragment of tRNA^Asn(GUU) of Chinese yew (Taxus chinensis), exhibiting stronger inhibitory effects than taxol against CRC progression. Mechanistically, tRF-T36 binds directly to the 3' UTR of NUCKS1 mRNA to downregulate its expressions via RNAi pathway. High-throughput RNA sequencing indicated that the downregulated NUCKS1 induced by tRF-T36 further inhibits PI3K/Akt pathway, as verified by the significantly efficacy decrease of tRF-T36 mimic in co-treatment with 740Y-P, an agonist of PI3K/Akt pathway. Collectively, our findings emphasize the importance of NUCKS1 as a promising druggable target for CRC. Furthermore, the present study provides the first siRNA sequence, tRF-T36 mimic, as small RNA drug candidate, thereby shedding light on CRC therapeutics.

1,097

News (Medical) associated with Paclitaxel

20 Jan 2025

·pipelinereview.com

European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer

LONDON, UK I January 20, 2025 I GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This approval broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU) to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which represent approximately 75% of patients diagnosed with endometrial cancer and who have limited treatment options. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said : “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit. We’re proud Jemperli continues to redefine the treatment landscape for patients.” Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark, and RUBY principal investigator said : “Clinicians have been waiting for years for an immuno-oncology-based option that can meaningfully improve overall survival outcomes for patients with MMRp/MSS primary advanced or recurrent endometrial cancer. The expanded approval represents a significant advance that delivers on this hope, now for patients with both dMMR/MSI-H and MMRp/MSS tumours.” The European Commission’s approval to expand the use of Jemperli plus chemotherapy is based on results from Part 1 of the RUBY phase III trial. RUBY Part 1 is the only clinical trial in this setting to show a clinically meaningful and statistically significant overall survival (OS) benefit in the full population of patients with primary advanced or recurrent endometrial cancer, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54–0.89) compared to chemotherapy alone. At the 2.5-year landmark, the chance of being alive was 61% (95% CI: 54-67) for patients in the Jemperli plus chemotherapy group (245 patients) compared to 49% (95% CI: 43-55) in the chemotherapy group (249 patients). In addition, a 16.4-month improvement in median OS was observed with Jemperli plus chemotherapy versus chemotherapy alone (44.6 months [95% CI: 32.6–NR] vs. 28.2 months [95% CI: 22.1–35.6], respectively). The median duration of follow-up was more than three years. 1 The safety and tolerability analysis from RUBY Part 1 showed a safety profile for Jemperli plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents. The most common treatment-emergent adverse reactions (≥ 10%) in patients receiving Jemperli plus chemotherapy were rash, rash maculopapular, hypothyroidism, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased and dry skin. OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on 16 March 2024, and were published in Annals of Oncology on 9 June 2024. The label for Jemperli plus chemotherapy in the US was expanded to all adult patients with primary advanced or recurrent endometrial cancer in August 2024. About endometrial cancer Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, 2 with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide. 3 Incidence rates are expected to rise by approximately 40% between 2020 and 2040. 4 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year. 5 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. 6 Among patients with primary advanced or recurrent endometrial cancer, approximately 75% have MMRp/MSS tumours. 7 About RUBY RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of 785 patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. In Part 1, the dual-primary endpoints are investigator-assessed progression-free survival (PFS) based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability. RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology. About Jemperli (dostarlimab) Jemperli , a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes. In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This includes patients with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Additionally, Jemperli is indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist. Important Information for Jemperli in the EU Indication Jemperli is indicated: Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU. GSK in oncology Oncology is an emerging therapeutic area for GSK where we are committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers, and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline

Clinical ResultDrug ApprovalPhase 3License out/inASCO

20 Jan 2025

·pipelinereview.com

Junshi Biosciences Announces Commercialization Partnership with LEO Pharma for Toripalimab in Europe

SHANGHAI, China I January 20, 2025 I Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced a distribution and marketing partnership with LEO Pharma for toripalimab in Europe. This collaboration aims to promote the accessibility of toripalimab in Europe, offering high-quality, innovative treatments to patients across up to 32 European countries. Toripalimab, independently developed by Junshi Biosciences, is a monoclonal antibody targeting PD-1 for the treatment of multiple malignant tumors. To date, toripalimab has been approved for marketing in over 35 countries and regions around the world. In 2024, toripalimab received approvals from both the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the following indications: 1) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); 2) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Toripalimab is the first and only drug in Europe for the treatment of NPC, and the only first-line treatment for advanced or metastatic ESCC, regardless of tumor PD-L1 expression status. Under the agreement, LEO Pharma will be responsible for toripalimab’s distribution, promotion, sales, etc., in up to 32 countries, including all member states of the European Union (EU) and the European Economic Area (EEA), as well as Switzerland and the United Kingdom. TopAlliance Biosciences Europe will remain the Marketing Authorization Holder (MAH) for toripalimab in Europe, retaining responsibility for product development, manufacturing, registration, pharmacovigilance, quality management, etc. LEO Pharma will make payments, including an upfront payment, milestone payments if LEO Pharma wishes to pursue any subsequently approved indications, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the collaboration territory. Dr. Sheng YAO, Senior Vice President of Junshi Biosciences and CEO of TopAlliance Biosciences , said, “The partnership with LEO Pharma has established a significant milestone for Junshi Biosciences in the European market and is closely aligned with the company’s global expansion strategy. Europe has been identified as a pivotal strategic region for the corporate business growth. As the Marketing Authorization Holder (MAH) of the product in Europe, the company has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe. As a century-old multinational pharmaceutical company headquartered in Europe, LEO Pharma has established a mature distribution network and rich marketing expertise in the local markets. By leveraging both parties’ strengths in R&D, manufacturing, and commercialization, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need. Moving forward, we will continue to implement our ‘In China, For Global’ strategy and work with partners to provide high-quality, innovative therapies from China to patients worldwide.” Jean Monin, Executive Vice President of Thrombosis Business Unit, LEO Pharma , commented, “We are excited to partner with Junshi Biosciences, supplementing LEO Pharma’s Thrombosis business, which already serves patients with cancer-associated thrombosis. The distribution and marketing partnership for LOQTORZI® brings an important new treatment option to areas of high unmet medical need and focuses on a specialty hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients. Leveraging our commercial platform, LOQTORZI® will create valuable synergies and drive continued growth.” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe, and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: The ten indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the globe, including the Singapore Health Sciences Authority (HSA). About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma also provides anti-coagulant therapy for cancer patients and other specialty patients. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. For more information, please visit: https://www.leo-pharma.com. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. SOURCE: Junshi Biosciences

Drug ApprovalLicense out/inAccelerated ApprovalCSCOImmunotherapy

20 Jan 2025

·www.prnewswire.com

SIRPAD - WORLD'S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT

TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ -- Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. Continue Reading Concept Medical proudly announces that over 1,250 patients have successfully enrolled in the SirPAD Trial. The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled trial is the world's largest study evaluating the treatment of Peripheral Artery Disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) versus uncoated balloons and one of the largest device studies ever performed for PAD. More than 1,250 patients have been enrolled and will be followed up at 12 months to assess the primary outcome of major adverse limb events (MALE). Final results are expected by Q1-Q2 2026. SirPAD is an investigator-initiated, multi-centre, randomized, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain old balloon angioplasty (POBA). The trial will also explore the potential for superiority. Principal Investigators Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco, from the University Hospital Zurich, who leads this ambitious study, said, "Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints. While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines. This result, having been able to randomize so many patients in a PAD device study, is unprecedented and we are very thankful to all investigators and patients for having supported the trial" on achieving the significant milestone of enrolling 1,250+ patients and successfully completing this phase of the study. With sirolimus-coated balloons gathering global momentum and MagicTouch PTA at the forefront, SirPAD is a crucial milestone in expanding the evidence for PAD treatment options. While patients with PAD have limited therapeutic avenues, SirPAD aims to bolster data supporting sirolimus-coated balloon technology. This large RCT was critical to evaluating treatment alternatives, and its year-long follow-up will provide much-anticipated answers. "At Concept Medical, we are committed to generating robust clinical evidence to support our innovative technologies. Following the successful completion of SIRONA—the largest superficial femoral artery (SFA) trial comparing our device against paclitaxel drug-coated balloons (DCBs), which demonstrated non-inferiority—we are proud to announce the completion of enrollment for another historical milestone: the largest randomised clinical trial for peripheral all-comers patients, completed enrolment of 1250+ patients. With this achievement, Concept Medical continues to lead the way with the most extensive and advanced clinical trial program in the field, reinforcing our position as a global pioneer in patient-centric vascular innovations," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. About Concept Medical Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus Coated Balloons (SCBs)—the world's first and most utilized SCB technology—well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy. For more information, please visit Photo: Logo: SOURCE Concept Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Study

100 Deals associated with Paclitaxel

External Link

KEGG	Wiki	ATC	Drug Bank
D00491	Paclitaxel	L01CD01	DB01229

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	EU	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	IS	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	LI	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	NO	Accord Healthcare SLU	05 Jan 2024
Platinum-Resistant Primary Peritoneal Carcinoma	EU	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	IS	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	LI	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	NO	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	EU	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	IS	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	LI	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	NO	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	EU	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	IS	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	LI	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	NO	Inceptua SA	20 Nov 2018
Germinoma	JP	Clinigen KK	21 Feb 2013
Germinoma	JP	Bristol Myers Squibb Co.	21 Feb 2013
Esophageal Carcinoma	JP	Bristol Myers Squibb Co.	21 Mar 2012
Esophageal Carcinoma	JP	Clinigen KK	21 Mar 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	NDA/BLA	EU	Accord Healthcare SLU	09 Nov 2023
Metastatic Pancreatic Cancer	Phase 3	CN	Shanghai Yizhong Pharmaceutical Co., Ltd.	02 Jan 2025
High grade glioma	Phase 3	CN	Zhejiang University	01 Apr 2024
Human epidermal growth factor 2 negative carcinoma of breast	Phase 3	CN	Shanghai Yizhong Pharmaceutical Co., Ltd.	25 Sep 2023
Triple Negative Breast Cancer	Phase 3	US	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	JP	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AR	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AU	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	AT	Hoffmann-La Roche, Inc.	25 Nov 2019
Triple Negative Breast Cancer	Phase 3	BE	Hoffmann-La Roche, Inc.	25 Nov 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04175912 (CTgov)	Phase 2	Unresectable Intrahepatic Cholangiocarcinoma \| Unresectable Hepatocellular Carcinoma \| Metastatic hepatocellular carcinoma ... View more	40	Pevonedistat (Arm A (Pevonedistat))	ihxztkydwc(lanayoufdo) = tshlrijgzy jxlmabqtux (kdvlgaiefb, rxmlnxkckp - ochvmapxje) View more	-	07 Jan 2025
				Carboplatin+Paclitaxel+Pevonedistat (Arm B (Pevonedistat, Paclitaxel, Carboplatin))	ihxztkydwc(lanayoufdo) = zxvjinrwit jxlmabqtux (kdvlgaiefb, jbcgioivvq - xezuushmcx) View more
NCT01897441 (CTgov)	Not Applicable	Metastatic breast cancer \| Breast Cancer 3 \| Advanced breast cancer	31	Cytology Specimen Collection Procedure+Trastuzumab+cyclophosphamide+Doxorubicin Hydrochloride+Paclitaxel (Stratum A: HER2-positive)	xnhcmijwkh(nuinymvcit) = jzgvxnpzia fpxusbsrdb (fyrpdjmnhu, fuxwpxiksr - hofryqejya) View more	-	24 Dec 2024
				Cytology Specimen Collection Procedure+cyclophosphamide+Doxorubicin Hydrochloride+Paclitaxel (Stratum B: HER2-negative)	xnhcmijwkh(nuinymvcit) = rdvnltwwwc fpxusbsrdb (fyrpdjmnhu, rngxepxmwp - vsdruuttbd) View more
ESMO_ASIA2024 Manual	Not Applicable	Head and Neck Neoplasms	104	Docetaxel plus Cisplatin	vrjuihijhc(slivwtfnbz) = dxfkxpyieh uolegthsej (xrvyqoujra ) View more	Similar	07 Dec 2024
				Paclitaxel plus Carboplatin	vrjuihijhc(slivwtfnbz) = dftbraprod uolegthsej (xrvyqoujra ) View more
ESMO_ASIA2024	Not Applicable	Squamous Cell Carcinoma	-	Paclitaxel plus carboplatin plus cetuximab (IC-PCE)	cstnieghrr(ygekqttawd) = ocggjewgdh sqdqvctgze (nyopxwuppb )	Positive	07 Dec 2024
				Docetaxel plus cisplatin plus S-1 (IC-TPS)	cstnieghrr(ygekqttawd) = nzfmkqlxyq sqdqvctgze (nyopxwuppb )
ESMO_ASIA2024	Not Applicable	Extramammary Paget Disease First line Serum lactate dehydrogenase level \| carcinoembryonic antigen levels	12	Paclitaxel 80 mg/m2	lhkqxevtnu(fbjuxfrcfm) = vkctbphpjh dbebycyefn (meprecabxx ) View more	Positive	07 Dec 2024
NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	kiaripqoij(fojphzjgxa) = kiidnrtnau ukjerawzkw (avnwxahygm, yfqccahnxr - gruvnsjaar) View more	-	05 Dec 2024
				Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	kiaripqoij(fojphzjgxa) = dslbujcmgn ukjerawzkw (avnwxahygm, eckkohiduw - dfjxmabxkm) View more
NCT03081689 (NADIM Study \| NADIM phase II trial \| ###DELETE \| 2016-003732-20 \| NADIM \| NADIM study-SLCG, CTgov)	Phase 2	Non-small cell lung cancer stage IIIA	46	Nivolumab 360 mg+Paclitaxel 200mg/m2+Carboplatin AUC 6	bcdahkqizw(zdzicokqew) = exgqfplxik hdffkmwkek (dcxavracjk, duyzkdhjxg - toqtzmjwxd) View more	-	04 Dec 2024
NCT01779206 (WSG-ADAPT, SABCS2024) Manual	Phase 2/3	Early Stage Breast Carcinoma	2,233	4 x sb-PAC 175 mg/m2 q2w	dryasqvecf(towoehfozv) = rtsvwejakk wdvjtyboeg (amfgzinzue ) View more	Positive	26 Nov 2024
				8 x nab-PAC 125 mg/m2 q1w	dryasqvecf(towoehfozv) = kjedkavzby wdvjtyboeg (amfgzinzue ) View more
NCT02934464 (ARMANI, Pubmed) Manual	Phase 3	HER2 negative Gastric Cancer \| HER2 negative Gastroesophageal Junction Adenocarcinoma Maintenance HER2 Negative	280	paclitaxel + ramucirumab	wgsnhztheb(mbsaqxzijt) = ualkcyccqt iqlgicmbpb (xswmqqbiqf, 5.9 - 7.8) View more	Positive	15 Nov 2024
				FOLFOX or CAPOX	wgsnhztheb(mbsaqxzijt) = cmdnjphdrt iqlgicmbpb (xswmqqbiqf, 2.8 - 4.2) View more
NCT03393884 (OVATION-2, SITC2024) Manual	Phase 1/2	Ovarian Epithelial Carcinoma First line	117	IMNN-001 + NACT	hyatzinlri(wecbllzvmb) = rxxgtylyct bmrdsovpmb (oivkqpryak ) View more	Positive	08 Nov 2024
				NACT	hyatzinlri(wecbllzvmb) = ezkusmuktw bmrdsovpmb (oivkqpryak ) View more

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