9 recruiting, 7 completed, 6 active not recruiting, 6 not yet recruiting. 24 Phase 2, 8 Phase 1, 5 Phase 3, 1 Not applicable.
Follow Liposomal irinotecan: new trials by email Literature Review of Liposomal irinotecan trials Research Report on Liposomal irinotecan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors Zanidatamab - Biliary Tract Cancer | Phase 2 | Not yet recruiting | Anhui Provincial Hospital | 15 | 2026-11-30 | 2026-10-01 |
| A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy Tambotatug pelitecan, Liposomal irinotecan, 5 Fluorouracil - Metastatic Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC) | Phase 3 | Not yet recruiting | MediLink Therapeutics (Suzhou) Co., Ltd. | 320 | 2026-10-01 | 2026-09-04 |
| Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases Liposomal Irinotecan, Oxaliplatin, Capecitabine - Colorectal Cancer Liver Metastases (CRLM), Colorectal Cancer | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 28 | 2026-05-30 | 2026-05-06 |
| Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer Liposomal Irinotecan - Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancers | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2026-05-30 | 2026-05-18 |
| Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil - Metastatic Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma | Phase 2 | Recruiting | Medical University of South Carolina | 52 | 2026-04-02 | 2026-05-06 |
| Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma Liposomal Irinotecan, Apatinib in arm1 - Osteosarcoma, Osteosarcoma Metastatic | Phase 1 / Phase 2 | Recruiting | Peking University People's Hospital | 56 | 2026-03-05 | 2026-03-18 |
| A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer Setidegrasib, Oxaliplatin, Leucovorin - Pancreatic Cancer, Metastatic Pancreatic Cancer | Phase 3 | Recruiting | Astellas Pharma Global Development, Inc. | 614 | 2026-02-17 | 2026-11-03 |
| SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC SCRT, Liposomal Irinotecan, Oxaliplatin - Rectal Cancer, Adenocarcinoma | Not applicable | Recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 49 | 2025-11-30 | 2026-03-16 |
| Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) RMC-6236, Gemcitabine, nab-paclitaxel - Pancreatic Cancer, PDAC | Phase 3 | Active not recruiting | Revolution Medicines, Inc. | 500 | 2024-10-16 | 2026-06-02 |
| Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer Liposomal Irinotecan, Oxaliplatin, S-1 - Pancreatic Cancer | Phase 3 | Not yet recruiting | CSPC Ouyi Pharmaceutical Co., Ltd. | 408 | 2024-09-01 | 2024-08-27 |
| Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC liposomal irinotecan, 5-FU, LV - Esophageal Cancer | Phase 3 | Not yet recruiting | Rui-hua Xu, MD, PhD | 360 | 2024-08-01 | 2024-07-15 |
| Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer Liposomal irinotecan, Bevacizumab - Colorectal Cancer | Phase 1 / Phase 2 | Unknown | Sun Yat-sen University | 74 | 2024-06-05 | 2024-05-30 |
| Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas Irinotecan liposome injection (S095013), Oxaliplatin, LLV (levoisomer form of leucovorin) - Metastatic Adenocarcinoma of the Pancreas | Phase 2 | Completed | Institut de Recherches Internationales Servier | 41 | 2024-04-25 | 2026-05-18 |
| Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer Liposomal irinotecan, Capecitabine, Bevacizumab - Colorectal Cancer | Phase 2 | Unknown | Harbin Medical University | 63 | 2024-04-01 | 2024-01-18 |
| Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease Vincristine, Dactinomycin, Cyclophosphamide - Rhabdomyosarcoma | Phase 2 | Recruiting | St. Jude Children's Research Hospital | 135 | 2024-03-13 | 2026-06-15 |
| Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer liposomal irinotecan, Capecitabine, Radiation threapy - Rectal Cancer | Phase 2 | Active not recruiting | Hebei Medical University Fourth Hospital | 60 | 2024-02-01 | 2026-08-03 |
| Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer liposomal irinotecan, 5-FU, LV - Colorectal Cancer | Phase 2 | Recruiting | Hebei Medical University Fourth Hospital | 173 | 2024-01-01 | 2024-10-09 |
| Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy - Metastatic Biliary Tract Cancer | Unknown | Tianjin Medical University Cancer Institute and Hospital | 30 | 2024-01-01 | 2024-02-28 | |
| NALIRIFOX as Induction Therapy in LAPC Liposomal irinotecan - Pancreatic Ductal Adenocarcinoma | Phase 2 | Unknown | The First Affiliated Hospital with Nanjing Medical University | 20 | 2023-12-25 | 2024-06-21 |
| Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer Liposomal irinotecan, TAS102, Bevacizumab - Metastatic Colorectal Cancer | Phase 2 | Recruiting | University of Wisconsin, Madison | 50 | 2023-10-13 | 2026-09-15 |
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Pancreatic Neoplasms (7) · Colorectal Neoplasms (6) · Biliary Tract Neoplasms (3) · Esophageal Neoplasms (2) · Neoplasm Metastasis (2) · Neoplasms (2) · Rectal Neoplasms (2) · Adenocarcinoma Of Esophagus (1) · Astrocytoma (1) · Brain Neoplasms (1) · Carcinoma, Neuroendocrine (1) · Carcinoma, Ovarian Epithelial (1) · Esophageal Squamous Cell Carcinoma (1) · Fallopian Tube Neoplasms (1) · Glioblastoma (1)
Tianjin Medical University Cancer Institute and Hospital (3) · Hebei Medical University Fourth Hospital (2) · University of Wisconsin, Madison (2) · Washington University School of Medicine (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Anhui Provincial Hospital (1) · Astellas Pharma Global Development, Inc. (1) · Astellas Pharma Inc (1) · CSPC Ouyi Pharmaceutical Co., Ltd. (1) · Changhoon Yoo (1) · ECOG-ACRIN Cancer Research Group (1) · Emory University (1) · Harbin Medical University (1) · Institut de Recherches Internationales Servier (1) · MediLink Therapeutics (Suzhou) Co., Ltd. (1)
United States (15) · China (10) · Japan (4) · France (3) · South Korea (3) · Spain (3) · Germany (2) · Puerto Rico (2) · United Kingdom (2) · Brazil (1) · Italy (1) · Netherlands (1) · Poland (1) · Taiwan (1)
Afsaneh Barzi, MD (1) · Albert Lockhart, MD (1) · Alberto Pappo, MD (1) · Ashley Frith, M.D. (1) · Changhoon Yoo (1) · Dustin Deming, MD (1) · Efrat Dotan (1) · Fengpeng Wu, Professor (1) · Guiying Wang, Professor (1) · Hongli Liu, Professor (1) · Jan M Prins, MD, PhD (1) · Kian-Huat Lim, M.D, Ph.D. (1) · Mairead McNamara (1) · Michael Prados, MD (1)
PMID 27871319, PMID 32029495, PMID 33835977, PMID 34656226, PMID 36951834, PMID 36963200, PMID 37287870, PMID 37753702, PMID 39987459, PMID 40147791, PMID 41879829, PMID 42223072, PMID 42371783
P30CA014089 (1), U10CA180820 (1)