Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Colorectal Cancer MetastaticColorectal Cancer Recurrent
Interventions
DRUG

Trifluridine/Tipiracil + Regorafenib

Trifluridine/tipiracil will be administered orally BID at a starting dose of 30 mg per square meter of body-surface area, on days 1 through 5 every 2 weeks. Regorafenib will be administered orally QD at a dose-escalation strategy (80 mg/day, followed by weekly increase of 40 mg to 120 mg/day), if no significant drug-related adverse events occurred and 120 mg/day for 21 days of a 28-day cycle.

DRUG

Trifluridine/tipiracil + bevacizumab

Trifluridine/tipiracil will be administered orally BID at a starting dose of 35 mg per square meter of body-surface area, on days 1 through 5 every 2 weeks. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered IV every 2 weeks (day 1 and day 15).

Trial Locations (1)

310000

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER