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Study identifier: NCT07047560 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Colorectal Cancer (CRC)  ·  Sponsor: Tianjin Medical University Cancer Institute and Hospital

PhasePhase 2
Planned participants46
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ting Deng, MD  ·  022-23340123  ·  xymcdengting@126.com

Always discuss trial participation with your own doctor first.

Locations (1)

Tianjin Medical University Cancer Institute and HospitalTianjin, Tianjin Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07047560