NCT05077839

Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC

Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer (TOBACO): a Randomized, Controlled, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• First-line Treatment
• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	Trifluridine/tipiracil was approved in the third-line treatment of advanced colorectal cancer. Its efficacy in the first-line treatment was unknown.

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-08-31
• Completion: 2025-08-31
• First posted: 2021-10-14
• Last updated: 2021-10-25

Locations

1 site across 1 country: China