Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study

Summary

This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR). Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.

Timeline

Start

2024-09-01

Primary completion

2026-08-01

Completion

2027-08-01

Drugs

Indications