NCT06341296

Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Detailed description

This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m\^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m\^2 d1, 5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome	70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.
DRUG	5-FU	5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
DRUG	LV	400mg/m\^2, d1, 14 days per cycle, 8 cycles.
DRUG	Bevacizumab	5mg/kg, d1, 14 days per cycle, 8 cycles.

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2024-04-02
• Last updated: 2024-08-12

Locations

1 site across 1 country: China