43 completed, 40 recruiting, 26 not yet recruiting, 22 unknown. 105 Phase 2, 45 Phase 1, 15 Phase 3, 4 Not applicable, 1 Early Phase 1.
Follow irinotecan sucrosofate: new trials by email Literature Review of irinotecan sucrosofate trials Research Report on irinotecan sucrosofate
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 |
|---|---|---|---|---|---|---|
| Liposomal Irinotecan Plus Cisplatin in Patients With Advanced or Metastatic Solid Malignancies Liposomal Irinotecan Plus Cisplatin - Advanced Solid Malignancies | Phase 1 | Not yet recruiting | National Health Research Institutes, Taiwan | 44 | 2026-12-01 | 2026-11-02 |
| 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 |
| NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months - Advanced Small Intestine Cancer, Appendiceal Cancers | Phase 1 | Recruiting | The Methodist Hospital Research Institute | 22 | 2026-09-18 | 2026-11-03 |
| 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 |
| Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI), Capecitabine - Rectal Cancer Patients | Phase 2 | Not yet recruiting | Guangdong Provincial People's Hospital | 44 | 2026-05-20 | 2026-04-13 |
| A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart, Irinotecan liposome + 5-FU/LV + Bevacizumab, Irinotecan + 5-FU/LV + Bevacizumab - Metastatic Colorectal Cancer (CRC), Liposomal Irinotecan | Phase 2 / Phase 3 | Not yet recruiting | Hebei Medical University Fourth Hospital | 408 | 2026-05-20 | 2026-05-13 |
| Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations Biospecimen Collection, Computed Tomography, Fluorouracil - Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma | Phase 3 | Recruiting | SWOG Cancer Research Network | 94 | 2026-05-13 | 2026-05-22 |
| 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 |
| NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial Biospecimen Collection, Computed Tomography, Fluorouracil - Borderline Resectable Pancreatic Ductal Adenocarcinoma | Phase 2 | Recruiting | Roswell Park Cancer Institute | 20 | 2026-03-02 | 2026-09-21 |
| Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors Liposomal Irinotecan, Vincristine, Temozolomide, and Optional Anlotinib - Relapsed or Refractory Pediatric Malignant Solid Tumors (Including Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma) | Phase 2 | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 33 | 2026-03-01 | 2026-03-03 |
| Efficacy and Safety of HAIC Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepatic Cholangiocarcinoma hepatic arterial infusion chemotherapy (Irinotecan liposome plus 5-FU/LV) combined with lenvatinib and PD-1 inhibitors - Intrahepatic Cholangiocarcinoma (Icc) | Phase 2 | Active not recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2026-02-24 | 2026-06-15 |
| 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 |
| Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy liposomal irinotecan monotherapy, Liposomal Irinotecan + rmhTNF-NC, Liposomal Irinotecan + Bevacizumab - Malignant Ascites | Phase 1 / Phase 2 | Recruiting | Dong sheng Zhang | 48 | 2025-11-28 | 2026-02-09 |
| Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy - Advanced Rectal Cancer | Phase 2 | Recruiting | Tianjin Medical University Cancer Institute and Hospital | 30 | 2025-11-01 | 2026-06-03 |
| A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer Bevacizumab,Irinotecan liposome (II),5-FU/LV - Colorectal Cancer | Phase 2 | Not yet recruiting | Sanjun Cai | 300 | 2025-09-01 | 2025-08-14 |
| Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer Biopsy Procedure, Biospecimen Collection, Capecitabine - Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8 | Phase 3 | Recruiting | NRG Oncology | 356 | 2025-08-21 | 2026-08-25 |
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Pancreatic Neoplasms (39) · Colorectal Neoplasms (19) · Neoplasms (8) · Small Cell Lung Carcinoma (8) · Stomach Neoplasms (7) · Biliary Tract Neoplasms (6) · Neoplasm Metastasis (5) · Cholangiocarcinoma (4) · Osteosarcoma (4) · Recurrence (4) · Rhabdomyosarcoma (4) · Sarcoma, Ewing (4) · Ovarian Neoplasms (3) · Esophageal Neoplasms (2) · Fallopian Tube Neoplasms (2)
Tianjin Medical University Cancer Institute and Hospital (7) · CSPC Ouyi Pharmaceutical Co., Ltd. (5) · Ipsen (5) · National Health Research Institutes, Taiwan (4) · Fudan University (3) · Hebei Medical University Fourth Hospital (3) · Institut de Recherches Internationales Servier (3) · Sun Yat-sen University (3) · The First Affiliated Hospital with Nanjing Medical University (3) · Washington University School of Medicine (3) · West China Hospital (3) · AIO-Studien-gGmbH (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (2) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (2) · Federation Francophone de Cancerologie Digestive (2)
United States (54) · China (53) · Spain (13) · France (12) · Germany (11) · South Korea (11) · Taiwan (11) · Canada (7) · Italy (7) · Japan (7) · United Kingdom (7) · Australia (6) · Belgium (5) · Brazil (4) · Hungary (4)
Abdullah Esmail, MD (1) · Abi Vainstein, MD (1) · Afsaneh Barzi, MD (1) · Albert Lockhart, MD (1) · Alberto Pappo, MD (1) · Andrew Hendifar, MD (1) · Antonio Cubillo, MD (1) · Arndt Vogel, Prof. (1) · Ashley Frith, M.D. (1) · Baorui Baorui Liu, Doctor (1) · Benjamin Weinberg, MD (1) · Benoist Chibaudel, MD (1) · Changhoon Yoo (1)
PMID 26615328, PMID 27871319, PMID 40147791, PMID 11230497, PMID 11489791, PMID 11895891, PMID 16271446, PMID 1651156, PMID 17468871, PMID 19349540, PMID 22811849, PMID 23406728, PMID 23880820, PMID 25577133, PMID 27091418, PMID 30414528, PMID 30525443, PMID 30654298, PMID 30842038, PMID 31401903, PMID 31789476, PMID 31856081, PMID 32029495, PMID 32451495, PMID 33201358, PMID 33214082, PMID 33284237, PMID 33403007, PMID 33835977, PMID 33957442, PMID 34656226, PMID 34750990, PMID 35195913, PMID 36056179, PMID 36410913, PMID 36734848, PMID 36951834, PMID 36963200, PMID 37010988, PMID 37056765, PMID 37287870, PMID 37600936, PMID 37708904, PMID 37753702, PMID 38648575, PMID 38870977, PMID 39492841, PMID 39701097, PMID 39746964, PMID 39987459
2017 (3), 2016 (2), 2019 (2), 2015 (1), 2018 (1), P30CA014089 (1), P30CA015083 (1), P30CA060553 (1), R21CA186140 (1), U10CA180820 (1), U10CA180868 (1), U10CA180888 (1), ZIABC011078 (1)