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RECRUITING
NCT07047560
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-09-01

Completion Date

2027-08-01

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DRUG

fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)

Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3, Q2W; Fluorouracil (5-FU): Q2W; * 400 mg/m² IV bolus on D1 * Followed by 2400 mg/m² continuous IV infusion over 46-48 hours Leucovorin (LV): 400 mg/m² IV infusion on D1 Bevacizumab: 5 mg/kg IV infusion on D1, Q2W.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China