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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT07585279
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Liposomal Irinotecan
  • Metastatic Colorectal Cancer (CRC)
  • Second-Line

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart — DRUG
    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes; Enlonstobart: 240mg, intravenous infusion for no less than 60 minutes;
  • Irinotecan liposome + 5-FU/LV + Bevacizumab — DRUG
    Irinotecan liposome: 70mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;
  • Irinotecan + 5-FU/LV + Bevacizumab — DRUG
    Irinotecan: 180mg/m², intravenous infusion within 90 minutes; 5-FU: 400mg/m², intravenous injection followed by 2400mg/m² continuous intravenous infusion within 46 hours; LV: 400mg/m², intravenous infusion within 30 minutes; Bevacizumab: 5mg/kg, intravenous infusion within 30-90 minutes;

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2032

Study Design

Enrollment
408 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
  • Experimental: Group B
  • Active Comparator: Group C

Primary Outcome Measure

ORR [ Time Frame: Around 4 years ]

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