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

NCT07585279 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart

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;

DRUG

Irinotecan liposome + 5-FU/LV + Bevacizumab

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;

DRUG

Irinotecan + 5-FU/LV + Bevacizumab

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;

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2031-02-28
Completion
2032-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585279 on ClinicalTrials.gov