302
Participants
Start Date
April 1, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
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.
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).
RECRUITING
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER