drugset / Trial / NCT07261709

Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial

NCT07261709

Phase 2 Not yet recruiting 236 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is an investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial designed to evaluate the efficacy and safety of trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil plus bevacizumab in the treatment of refractory metastatic colorectal cancer.

Timeline

Start
2025-12-01
Primary completion
2027-10-30
Completion
2028-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Fruquintinib Small molecule 4 mg Oral
Background Trifluridine/tipiracil Unknown 35 mg/m2 Oral

Indications