MedTrace Logo

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

NCT07123441 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-14

No results posted yet for this study

Summary

This is a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of irinotecan liposome (II), 5-FU/LV in combination with bevacizumab for the treatment of advanced colorectal cancer.

Conditions

Interventions

DRUG

Bevacizumab,Irinotecan liposome (II),5-FU/LV

Bevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study.

Sponsors & Collaborators

  • Sanjun Cai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2028-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07123441 on ClinicalTrials.gov