A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer

English Translation (for ClinicalTrials.gov Patient-Friendly Summary):
This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1 protein.
This study is testing the effectiveness of a combination of three medications:
1. Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues.
2. Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply.
3. Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells.
The primary goal of this study is to evaluate how well this three-drug combination works and to monitor its safety. Participants will receive the study drugs via intravenous infusion or oral tablets according to the protocol. Their progress will be tracked with CT scans and blood tests every three months. Regular follow-up visits will continue even after stopping treatment to monitor long-term outcomes.
Who can participate? Participants must be adults diagnosed with advanced gastric cancer who have progressed after only one prior first-line standard therapy, have PD-L1-positive tumors, and have no severe heart, liver, or kidney disease. Pregnant or breastfeeding women cannot participate.
Possible side effects Potential side effects may include nausea, vomiting, diarrhea, hand-foot swelling, low blood cell counts (which can increase infection risk), and fatigue. The research team will closely monitor all participants and provide prompt treatment for any side effects.
Important note This study is still in the clinical trial phase. While it offers a potential new treatment option beyond standard care, there is no guarantee that the drugs will be effective for every participant.
For more information, please contact the research team.

Start Date01 Oct 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

[+1]

NCT07782346

/ Not yet recruitingPhase 1

Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)

Phase I trial, Multiple centers, open-label, non-randomized single-arm study

Start Date01 Oct 2026

Sponsor / Collaborator

National Health Research Institutes

[+7]

NCT07806110

/ Active, not recruitingPhase 2IIT

A Prospective, Phase II Study of Gemcitabine and Nab-paclitaxel in Combination With Liposomal Irinotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable/Borderline Resectable Pancreatic Cancer.

Based on the superior efficacy and safety profile of liposomal irinotecan over irinotecan in pancreatic cancer, as well as preliminary results from earlier studies evaluating nab-paclitaxel and gemcitabine (AG) combined with liposomal irinotecan, this study aims to further evaluate the efficacy and safety of liposomal irinotecan plus AG as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer (RPC/BRPC). The ultimate goal is to identify a more effective treatment regimen to prolong overall survival in this patient population.

Start Date30 Jul 2026

Sponsor / Collaborator

The First Hospital of Jilin University

100 Clinical Results associated with Irinotecan Hydrochloride Lioposome

100 Translational Medicine associated with Irinotecan Hydrochloride Lioposome

100 Patents (Medical) associated with Irinotecan Hydrochloride Lioposome

5,938

Literatures (Medical) associated with Irinotecan Hydrochloride Lioposome

01 Aug 2026·DRUG DEVELOPMENT RESEARCH

Applications of Bioinorganic Nano‐Based Delivery Systems—Diagnostics and Therapeutics

Review

Author: Fernandes, Donald ; Ssengooba, Frank ; Andrew, Jubilee

ABSTRACT:

Nanotechnology has emerged as a promising avenue for producing nanomedicines as alternatives to conventional drugs. Many organic nanoparticles, such as liposomes used in formulations like Doxil, Onivyde, and Marqibo, are approved by the Food and Drug Administration (FDA) and instrumental in treating various types of cancers. However, due to the many challenges associated with these formulations, alternative delivery systems have been explored, particularly those derived from inorganic sources. In particular, bioinorganic nano‐based delivery systems (BNDSs) such as gold, silver, platinum, silicon‐based, metal oxide and hybrid nanoparticles have been found to be useful in treating cancer and infectious and noncommunicable diseases. This review presents the most commonly used BNDSs, providing an in‐depth discussion on their use as therapeutic and imaging agents, the challenges associated with their use and current trends and future perspectives in their development for enhancing efficacy.

01 Aug 2026·ESMO Open

Impact of prior conventional irinotecan use on nanoliposomal irinotecan efficacy in advanced pancreatic cancer: a meta-analysis

Review

Author: Peters, M L ; Roshan, K ; Lee, S ; Modest, A M ; Keko, M ; Correa, T L ; Bockorny, B ; Birda, V

BACKGROUND:

Nanoliposomal irinotecan (nal-IRI) has become an established therapy for advanced pancreatic ductal adenocarcinoma (PDAC), both in the post-gemcitabine setting and, more recently, in the first-line NALIRIFOX regimen. Concerns remain regarding cross-resistance in patients previously exposed to conventional irinotecan. We performed a systematic review and meta-analysis to evaluate the impact of prior irinotecan exposure on outcomes with nal-IRI.

MATERIALS AND METHODS:

We conducted a systematic literature search of PubMed, Embase, and the Cochrane Library through July 2025 following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Eligible studies included patients with advanced PDAC treated with nal-IRI-containing regimens and reported outcomes stratified by prior irinotecan exposure. Data extraction and risk of bias assessments were performed independently by two reviewers. Hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) were pooled using random-effects models. Sensitivity and publication bias analyses were conducted.

RESULTS:

Thirteen retrospective studies comprising 2271 patients were included. One-third (33.1%) had received conventional irinotecan before nal-IRI. Prior irinotecan exposure was associated with inferior outcomes: pooled unadjusted and adjusted HRs for OS were 1.48 [95% confidence interval (CI) 1.24-1.76, P = 0.001] and 1.42 (95% CI 1.03-1.96, P = 0.030), respectively. For PFS, pooled unadjusted and adjusted HRs were 1.45 (95% CI 1.28-1.64, P < 0.001) and 1.72 (95% CI 1.16-2.54, P = 0.007), respectively. Patient-level subgroup analyses indicated that patients discontinuing prior irinotecan due to progression had significantly worse OS compared with those discontinuing for other reasons (HR 1.97, 95% CI 1.10-3.52). Most studies were high quality, and sensitivity analyses confirmed the robustness of the findings.

CONCLUSION:

Prior exposure to conventional irinotecan, particularly discontinuation for progression, reduced clinical benefit from subsequent nal-IRI therapy in advanced PDAC in observational cohorts. These findings support caution when considering nal-IRI soon after irinotecan progression and highlight the need for prospective sequencing studies.

06 Jul 2026·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Efficacy and safety of nanoliposomal irinotecan plus 5-fluorouracil and l-leucovorin in rare histological subtypes of pancreatic cancer

Article

Author: Takahashi, Hideaki ; Mitsunaga, Shuichi ; Amisaki, Masataka ; Inoue, Kanae ; Ikeda, Masafumi ; Igarashi, Go ; Taira, Tomonao ; Sasaki, Mitsuhito ; Satake, Tomoyuki ; Imaoka, Hiroshi ; Shibuki, Taro

Abstract:

Background:

Pancreatic cancers other than pancreatic ductal adenocarcinoma (PDAC) are rare and heterogeneous, accounting for fewer than 5%–7% of all pancreatic cancers. These include acinar cell carcinoma, undifferentiated carcinoma, adenosquamous carcinoma, colloid carcinoma, neuroendocrine carcinoma (NEC), mixed neuroendocrine–non-neuroendocrine neoplasm (MiNEN), and invasive intraductal papillary mucinous carcinoma (IPMC). Optimal treatment strategies, including sequencing and later-line options, remain unclear. Although nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU) and l-leucovorin (LV) is effective in gemcitabine-refractory PDAC, its role in these rare subtypes is unknown.

Methods:

We retrospectively analyzed nine patients with one of these rare subtypes who received nal-IRI plus 5-FU and LV between June 2020 and November 2024. Efficacy and safety were evaluated.

Results:

The cohort included two cases each of IPMC and adenosquamous carcinoma, and one case each of colloid carcinoma, undifferentiated carcinoma, acinar cell carcinoma, NEC, and MiNEN. Partial responses were observed in four patients, including undifferentiated carcinoma, acinar cell carcinoma, NEC, and MiNEN, even among tumors refractory to gemcitabine- or platinum-based regimens. Disease control was achieved in seven patients (77.8%). The median progression-free survival was 6.8 months. Disease control exceeding 12 months was observed in three patients. Median overall survival from first-line therapy was not reached. Treatment-related toxicities were generally manageable, with neutropenia being the most common grade ≥ 3 adverse event.

Conclusion:

Nal-IRI plus 5-FU and LV showed antitumor activity and was tolerable among the nine patients analyzed in this study, suggesting it may be a therapeutic option in second- or later-line settings for rare pancreatic cancer.

133

News (Medical) associated with Irinotecan Hydrochloride Lioposome

24 Aug 2026

·allsci.com

Columbia-led trial reports 64% response rate in small Phase II for four-drug CXCR4 regimen

A four-drug regimen combining the CXCR4 antagonist motixafortide (APHEXDA) with cemiplimab and chemotherapy produced responses in seven of 11 treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (PDAC), according to Phase II pilot data published August 21 in Nature Communications. The study pairs the early clinical signal with single-cell evidence that CXCR4 blockade may help reshape the immune-resistant PDAC tumor microenvironment. The study enrolled 11 treatment-naïve patients with metastatic PDAC and treated them with the four-agent combination — referred to as MCGN — comprising motixafortide, cemiplimab, gemcitabine, and nab-paclitaxel. Corresponding authors Kenneth P. Olive, Benjamin Izar, and Gulam A. Manji led the work through Columbia University Irving Medical Center's Herbert Irving Comprehensive Cancer Center, with collaborators at Brown University's Legorreta Cancer Center, Memorial Sloan Kettering Cancer Center, the Huntsman Cancer Institute at the University of Utah, the University of North Carolina, and the Case Comprehensive Cancer Center. In the 11-patient pilot cohort, the regimen produced an objective response rate (ORR) of 64%, a confirmed partial response rate of 55%, and a disease control rate (DCR) of 91%, according to the paper. Four of the 11 patients remained progression-free after more than one year. Median progression-free survival and overall survival figures from the pilot phase have been reported at scientific meetings, though these are from a small, single-arm cohort without a contemporaneous comparator. Motixafortide is FDA-approved under the brand name APHEXDA — in combination with filgrastim — for hematopoietic stem cell mobilization in multiple myeloma, marketed by BioLineRx. In the metastatic PDAC context it remains investigational. Cancer-associated fibroblasts in the PDAC tumor microenvironment (TME) secrete CXCL12, which signals through CXCR4 on immune cells to physically exclude cytotoxic T cells from the tumor — a principal reason checkpoint inhibitors have failed in this disease. Motixafortide blocks CXCR4, with the goal of disrupting this exclusion barrier and permitting T-cell infiltration that cemiplimab can then sustain. Single-nucleus RNA sequencing (snRNA-seq) of serial biopsies in responding patients revealed decreased tumor heterogeneity and reduced epithelial-to-mesenchymal transition states compared with resistant patients. Responders showed enrichment of CXCL12-expressing cancer-associated fibroblasts, the paper reported, consistent with the proposed mechanism and potentially identifying a TME-based biomarker of response. Two prior attempts to combine CXCR4 blockade with checkpoint inhibition in PDAC produced limited clinical benefit. The MORPHEUS-PDAC trial of motixafortide plus the anti-PD-L1 antibody atezolizumab in pretreated patients showed insufficient efficacy across all atezolizumab combinations, according to results published in The Oncologist in April 2026. A Phase II study at Johns Hopkins (NCT04177810) pairing plerixafor, a different CXCR4 antagonist, with cemiplimab confirmed T-cell recruitment but identified immunosuppressive macrophage infiltration as a co-resistance mechanism, according to results published in OncoImmunology in 2025. The addition of gemcitabine and nab-paclitaxel in the current regimen addresses the hypothesis that chemotherapy-mediated cytotoxic activity and potential immunogenic priming are necessary to overcome residual resistance. An earlier proof-of-concept for the CXCR4-plus-checkpoint-plus-chemotherapy approach came from the COMBAT/KEYNOTE-202 trial (NCT02826486), sponsored by Israel-based BioLineRx (Nasdaq: BLRX), which used motixafortide with pembrolizumab and a nanoliposomal irinotecan plus 5-FU/leucovorin backbone in previously treated patients. BioLineRx also provides motixafortide as drug supply for the current Columbia-sponsored trial; Regeneron provides cemiplimab. Based on the pilot results, the trial (NCT04543071) has been amended to a randomized, multicenter Phase II expansion comparing MCGN against gemcitabine and nab-paclitaxel alone in treatment-naïve patients. BioLineRx has described this as the first large, multicenter, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line chemotherapy in metastatic PDAC. A prespecified interim/futility analysis was anticipated to read out in 2026, according to BioLineRx's 2025 annual financial results published in March 2026. The study is limited by the small pilot cohort size, the absence of a randomized comparator in the reported data, and the single-institution design of the pilot phase. Spot something wrong? Report an issue with this article

Phase 2Clinical ResultDrug ApprovalPhase 1Financial Statement

01 Jun 2026

·allsci.com

ASCO: Revolution Med posts full Phase III pancreatic cancer data set for daraxonrasib

Revolution Medicines (Nasdaq: RVMD) released the full Phase III dataset at this year’s American Society of Clinical Oncology (ASCO) meeting showing that daraxonrasib, an oral RAS(ON) multi-selective inhibitor, cut the risk of death by 60% compared to standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The results confirm the earlier release of topline figures, and represent one of the largest survival improvements ever reported in a Phase III trial for previously treated metastatic PDAC and could establish the first broadly applicable targeted therapy for the majority of patients with RAS-driven disease. The RASolute 302 trial is a global, randomized Phase III study that enrolled 500 patients with previously treated metastatic PDAC, including those with RAS G12 mutations and a smaller group without an identified tumor RAS mutation. Patients were randomized to 300 mg oral daraxonrasib once daily or investigator’s choice of four cytotoxic chemotherapy regimens. At a February 2026 data cutoff, median OS in the RAS G12 population reached 13.2 months with daraxonrasib versus 6.6 months with chemotherapy (HR 0.40; 95% CI: 0.30–0.54; p \< 0.0001); results in the intent-to-treat population were nearly identical. Median PFS doubled as well, at 7.3 versus 3.5 months in the RAS G12 group (HR 0.45; p \< 0.0001), and objective response rates were 33.2% versus 11.8%. The safety profile favored daraxonrasib on most measures: Grade 3 or higher treatment-related adverse events occurred in 43.6% of patients on daraxonrasib versus 57.5% on chemotherapy, and treatment discontinuation due to adverse events was strikingly low at 1.2% versus 11.2%. The most common high-grade events with daraxonrasib were rash and stomatitis; one fatal pneumonitis was reported. Results were simultaneously published in The New England Journal of Medicine as well as featuring in the ASCO 2026 Annual Meeting plenary session. Daraxonrasib works by blocking the interaction between active RAS(ON) proteins — both wild-type and mutant forms — and their downstream effectors, a mechanistic approach distinct from the allele-specific KRAS(OFF) inhibitors that have reshaped lung cancer treatment. In the broader PDAC landscape, current second-line treatment largely relies on chemotherapy regimens such as Onivyde-based combinations and fluoropyrimidine-containing protocols, which typically deliver median overall survival measured in months rather than years. Biomarker-selected approvals for Merck’s Keytruda (pembrolizumab) and AstraZeneca’s Lynparza (olaparib) reach perhaps 10% of patients collectively. Cross-trial comparisons are limited, but no prior Phase III trial in any line of PDAC therapy has reported a median OS exceeding one year. Revolution Medicines intends to file a New Drug Application with the FDA under the Commissioner’s National Priority Voucher program; an expanded access protocol is already open. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Clinical ResultASCOAccelerated ApprovalDrug Approval

04 May 2026

·www.prnewswire.com

XtalPi -Enabled PharmaEngine PEP08 Achieves Enrollment Milestone, with Second Synthetic Lethality Program Underway

SHENZHEN, China, May 4, 2026 /PRNewswire/ -- XtalPi (2228.HK), a leading AI- and robotics-powered innovation platform, today announced dual breakthroughs in its strategic partnership with PharmaEngine (4162.TWO) PEP08, a next-generation PRMT5 inhibitor discovered via XtalPi's platform, has successfully begun enrollments in a Phase I solid tumor trial, achieving a new clinical milestone. Built upon the success of PEP08 at the drug discovery stage, the two companies initiated a second project, targeting a different undisclosed synthetic lethality mechanism. PEP08 received clinical clearance in June 2025 and is currently in Phase I evaluation for solid tumors in Australia and the Taiwan region. The enrollment milestone underscores XtalPi's ability to deliver differentiated molecules with strong drug-like properties, while demonstrating the program's steady clinical advancement. Leveraging XtalPi's integrated quantum physics-, AI-, and robotics-powered platform, PEP08 was designed to overcome the dose-limiting hematological toxicities seen with first-generation PRMT5 inhibitors. The molecule exploits an innovative MTA-cooperative binding mode to specifically target MTAP-deleted tumors—a genomic alteration found in 10-15% of all human cancers, with higher frequencies observed in NSCLC, pancreatic cancer, glioblastoma, and more. Preclinical data presented at 2025 AACR show PEP08 achieving superior efficacy compared to other clinical-stage MTA-cooperative PRMT5 inhibitors across multiple MTAP-deleted tumor models, supporting a potential best-in-class profile. Driven by the success of PEP08 at the drug discovery stage, the partnership expanded into a second project. By combining PharmaEngine's deep oncology expertise with XtalPi's AI and robotics molecular design engine, the duo aims to capture additional market share in the synthetic lethality space. Synthetic lethality is widely recognized as challenging yet highly promising frontier in oncology. According to Globocan and industry data, the global market is expected to grow from $4.2 billion to $17.6 billion by 2033, at a 17.3% CAGR. In recent years, several early-stage licensing deals in this space have exceeded $1 billion USD, further underscoring the immense clinical value and commercial appetite for this category. The clinical advancement of PEP08 and the ongoing collaboration of the second project serve as a dual validation of XtalPi's AI+robotics discovery engine. By repeatedly meeting rigorous benchmarks in complex target spaces, XtalPi has built a reproducible innovation model that turns deep know-how into high-value clinical assets. Underpinned by a milestone-sharing structure, this model tightly aligns the platform's evolution with clinical success, quickly translating biological insights into tangible impact for partners and patients around the world. Dr. Shuhao Wen, Chairman of XtalPi commented, "The clinical progress of PEP08 and the ongoing collaboration of the second project are testaments to the synergy between our teams, and highlights the reliability of XtalPi's R&D platform in tackling complex targets. We look forward to further applying this model to deliver high-quality pipeline assets for our partners and generate sustained value for our shareholders." "PharmaEngine has been advancing its R&D capabilities, and our collaboration with XtalPi exemplifies our ability to harness innovative technologies to propel next-generation discoveries in precision oncology," said Dr. Hong-Ren Wang, CEO and President of PharmaEngine. "XtalPi's R&D platform played a key role in the early-stage discovery of PEP08, providing a robust foundation for its clinical entry. Our collaboration of PEP08 and the second project demonstrates our ongoing efforts to advance cancer treatment development worldwide. About PharmaEngine, Inc. PharmaEngine, Inc. (4162.TWO), headquartered in Taipei, began operations in February 2003. PharmaEngine focuses on new drug development by adopting "Virtual Pharmaceutical Company Business Model". PharmaEngine has one commercial product, ONIVYDE®, which is currently approved for the treatment of adult patients with metastatic pancreatic adenocarcinoma. In addition, PharmaEngine is advancing PEP07 (CHK1 inhibitor) and PEP08 (MTA-collaborative PRMT5 inhibitor) through Phase I clinical trials. Leveraging its extensive experience in drug development and project management, the Company aims to continue expanding its pipeline. PharmaEngine also pursues international collaborations and out-licensing agreements to accelerate the discovery, development, and commercialization of novel cancer therapies. About XtalPi XtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three physicists from the Massachusetts Institute of Technology (MIT). It is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics. By integrating first-principles calculations, AI algorithms, high-performance cloud computing, and standardized automation systems, XtalPi provides digital and intelligent R&D solutions for companies in the pharmaceutical, materials science, agricultural technology, energy, new chemicals, and cosmetics industries. SOURCE XtalPi Inc. 21% more press release views with Request a Demo

Phase 1License out/inDrug Approval

100 Deals associated with Irinotecan Hydrochloride Lioposome

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	Australia	Servier Laboratories (Australia) Pty Ltd.	19 Dec 2016
Pancreatic adenocarcinoma	European Union	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Iceland	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Norway	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic Cancer	United States	Ipsen Biopharmaceuticals, Inc.	22 Oct 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Ductal Adenocarcinoma	NDA/BLA	United States	Ipsen SA	14 Jun 2023
Extensive stage Small Cell Lung Cancer	Phase 3	United States	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	China	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Australia	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	France	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Germany	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Hungary	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Italy	Ipsen SA	25 Apr 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IRLCRC-1 (ESMO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma First line	68	Irinotecan liposome + 5-FU/LV + bevacizumab	qetasrijbd(wqxwageapu) = sjjismuavu ooojrwjwdd (mkunbipnyb ) View more	Positive	02 Jul 2026
NCT06662006 (ASCO2026)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma Second line	46	NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort A)	gylfqgiydu(tdixuwxsmr) = umkztvwiap emenlorcop (cswzuqqmxq, 1.9 - 32.9) View more	Positive	29 May 2026
NCT06662006 (ASCO2026)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma Second line	46	NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort B)	gylfqgiydu(tdixuwxsmr) = agdmdtuddr emenlorcop (cswzuqqmxq, 12.0 - 64.9) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Pancreatic adenocarcinoma metastatic Second line	68	Nanoliposomal irinotecan + fluorouracil and leucovorin (nal-IRI+5-FU/LV)	ucwcmxeztg(ldpkpebldn) = wbddgaiexm poliudjopa (jkhqlyiger, 4.5 - 6.7) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Pancreatic adenocarcinoma metastatic Second line	68	Nanoliposomal irinotecan + fluorouracil and leucovorin (nal-IRI+5-FU/LV) (>65 years old + gemcitabine-refractory metastatic pancreatic adenocarcinoma)	miezonxeoq(yjujbevdek) = dieochceeq bjrkcawzok (zvwlrpedlr )	Positive	29 May 2026
NCT04005339 (NAPOLI-2, ASCO2026)	Phase 2	Biliary Tract Neoplasms Second line	48	Nanoliposomal irinotecan + leucovorin + fluorouracil	psrwbjxbzx(dapjcjccsc) = bewhlpcllk tehxhtsphm (xksmhbpwoq ) View more	Positive	29 May 2026
NCT03785873 (BilT-03 \| BilT03, CTgov)	Phase 1/2	Advanced biliary tract cancer	34	Nivolumab+leucovorin+Nanoliposomal-Irinotecan+5-fluorouracil	qyldsnouam = gcrfhbldkg atyukcxpzj (volbxhiiff, jbkifhhaxz - qzfctmpnri) View more	-	13 Feb 2026
NCT05854498 (ASCO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma KRAS	25	Nanoliposomal irinotecan + TAS102 + bevacizumab	wcujwbrwfh(sjehexdngq) = blmjxvcric igkfvzoyxm (oytilgnmir ) View more	Positive	08 Jan 2026
NCT06538623 (ESMO2025)	Phase 2	Pancreatic Cancer Second line	22	Oxaliplatin + liposomal irinotecan II	zoyemtaxpc(asugxrwube) = jxhyykvzkt dnluebawsk (hbnqpkjwam ) View more	Positive	17 Oct 2025
NCT06782685 (ESMO2025)	Phase 1/2	Metastatic Pancreatic Cancer Second line	12	Nanoliposomal irinotecan + oxaliplatin + bevacizumab	jvwosqoydp(fhsnauxmwn) = The MTD was determined to be nal-IRI 50 mg/m, oxaliplatin 60 mg/m, and bevacizumab 5 mg/kg, administered every 2 weeks. cmtqebftrt (lnyewwtodc ) View more	Positive	17 Oct 2025
NCT03524508 \| NCT03043547 (NALIRICC, Pubmed \| J Hepatol) Manual	Phase 2	Biliary Tract Neoplasms Second line	278	nal-IRI plus 5-FU/LV	aafvggoeax(zxmyfyvctq) = qytfdygyhr wgkyzgowil (isgqhikxqf, 2.7 - 4.4) View more	Positive	01 Oct 2025
	Phase 2	Biliary Tract Neoplasms Second line	278	5-FU/LV	aafvggoeax(zxmyfyvctq) = kjkunfsipo wgkyzgowil (isgqhikxqf, 1.5 - 2.6) View more	Positive	01 Oct 2025
NCT03712397 (Pubmed \| Cancer Med)	Phase 2	Esophageal Squamous Cell Carcinoma \| Head and Neck Neoplasms	59	Nanoliposomal Irinotecan + 5‐Fluorouracil + Leucovorin	ngeuwrgdrq(sctqjvucxe) = lqmynsiydj rjlqwuerlo (bhwbigheau ) View more	Positive	01 Oct 2025
NCT03712397 (Pubmed \| Cancer Med)	Phase 2		59	Nanoliposomal Irinotecan + 5‐Fluorouracil + Leucovorin (HNSCC)	ngeuwrgdrq(sctqjvucxe) = pjvyrtzsre rjlqwuerlo (bhwbigheau ) View more	Positive	01 Oct 2025

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