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A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer

StatusNot Yet Recruiting
PhasePhase 2/3
Started2026-05-20
View on ClinicalTrials.gov ↗
Phase II - Treatment Regimen Exploration Stage: 1. Evaluate the safety and efficacy of the following three treatment regimens: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C) 2. Provide a basis for selecting the treatment regimen for the confirmatory phase. 3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens. Phase III - Efficacy Confirmation Stage: Compare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.
Trial Details
NCT Number NCT07585279
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Metastatic Colorectal Cancer (CRC), Liposomal Irinotecan, Second-Line
Enrollment 408 participants
Start Date 2026-05-20
Primary Completion 2031-02-28 (estimated)
Study Completion 2032-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-13