Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC
Status:
Recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
This is a two-group, parallel, randomized, standard-control phase II study comparing the
safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab
versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. This
study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical
University Cancer Institute and Hospital.
Patients with advanced colorectal cancer will be randomly assigned (1:1) to
trifluridine/tipiracil combined with oxaliplatin and bevacizumab (experimental group) or
XELOX plus bevacizumab (control group) after signing informed consent. In this study, 184
patients will be enrolled, 92 patients will receive trifluridine/tipiracil combined with
oxaliplatin and bevacizumab and 92 patients will receive standard therapy.
In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally
taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on
d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil
and bevacizumab maintenance treatment. Patients enrolled in this group could acquire
trifluridine/tipiracil free of charge.
The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin
130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner),
d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and
bevacizumab maintenance treatment.
Patients received regular and periodic reviews, with imaging evaluations every 8 weeks.
Safety will be evaluated by AE and laboratory tests. All patients were followed up every 3
months until death according to the plan.
Phase:
Phase 2
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital