NCT07123441

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sanjun Cai · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China