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
Study ID
NCT07047560
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Sep 1, 2024
Status verified
Jun 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV and bevacizumab
    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

Primary Outcome Measure

Objective Response Rate,ORR [ Time Frame: 6 months ]

Central Contacts

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