RecruitingPhase 2NCT07047560

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

Enrollment

46 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new chemotherapy regimen — a fractionated (split-dose) version of liposomal irinotecan (a specially packaged form of a chemo drug) combined with 5-FU/leucovorin and bevacizumab — as a second-line treatment for advanced colorectal cancer that progressed after oxaliplatin-based first-line therapy. **You may be eligible if...** - You are 18 or older with confirmed advanced colorectal cancer - Your cancer progressed during or within 6 months of first-line oxaliplatin-based chemotherapy, or within 1 year after completing adjuvant oxaliplatin treatment - Your general health score (ECOG) is 0 or 1 - You have measurable disease on scans - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - You have another active cancer history (except fully treated basal cell or cervical in situ) - You have uncontrolled high blood pressure or recent heart attack/heart failure - You have active brain metastases - You have had recent bowel perforation, fistula, or abdominal surgery complications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfractionated 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

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NCT07047560


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