NCT05969899

Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer

Prospective and Exploratory Study of Liposomal Irinotecan Based FOLFIRI Combined With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on NCI-CTCAE 5.0

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRI+Bevacizumab	irinotecan liposome 60 mg/m2, iv, for at least 90 minutes LV 400 mg/m2, iv, for at least 2 hours FU 400 mg/m2, iv, followed by FU 2400 mg/m2, iv for at least 46 hours bevacizumab 5mg/kg IV. The above scenario is repeated every two weeks. Patients were treated until disease progression, toxic intolerance, initiation of a new antitumor therapy, withdrawal of knowledge, or investigator judgment that subjects should withdraw from study therapy.

Timeline

• Start date: 2023-07-10
• Primary completion: 2025-07-10
• Completion: 2027-02-10
• First posted: 2023-08-01
• Last updated: 2024-11-21

Locations

1 site across 1 country: China