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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

All study participants must sign the informed consent form before any study-related procedures are initiated.

Aged 18-75 years, both males and females.

Histologically confirmed unresectable colorectal cancer.

RAS status known (mutant or wild-type).

Disqualifiers

1.Prior treatment with trifluridine/tipiracil, fruquintinib, or any other VEGF-receptor tyrosine-kinase inhibitor (e.g., apatinib, regorafenib, anlotinib).

Trial design

Treatments tested in this trial

  • Trifluridine/tipiracil plus fruquintinib
  • trifluridine/tipiracil plus bevacizumab

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators