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

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

Trial Details

NCT ID
NCT07047560
Phase
PHASE2
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)
Locations (sample)
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • Signed the informed consent；
  • Male or female patients ≥18 years old;
  • ECOG physical status score is 0 or 1;
  • Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);

For full eligibility, visit ClinicalTrials.gov.

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