NCT07286695

Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer

A Multicenter, Open-label, Randomized Controlled Study of Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil in the Treatment of Patients With Advanced Metastatic Colorectal Cancer Who Failed Standard Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with chemotherapy. Trifluridine/tipiracil plus bevacizumab is also a standard treatment for mCRC. This study aims to explore the efficacy and safety of fruquintinib combined with trifluridine/tipiracil versus bevacizumab combined with trifluridine/tipiracil in the treatment of patients with advanced metastatic colorectal cancer who failed standard chemotherapy.

Detailed description

Phase II study comprises a safety run-in stage, and a randomized treatment stage. Phase II (safety run-in stage): It aims to evaluate the safety and tolerability of combination therapy-comprising trifluridine/tipiracil and fruquintinib. Trifluridine/tipiracil was administered at a descending dose level starting from 35 mg/m² each time alongside fixed dose of fruquintinib in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Phase II (randomized treatment stage): Upon determination of the recommend dose of trifluridine/tipiracil based on prior data, a randomized controlled study will be conducted in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Patients will be randomly assigned to two arms: experimental arm: Fruquintinib and trifluridine/tipiracil; active comparator arm: Bevacizumab and trifluridine/tipiracil.

Conditions

• Metastatic Colorectal Cancer (CRC)
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib Combined With trifluridine/tipiracil	Experimental arm: Fruquintinib: 4mg once daily for 21 days on/7 days off, every 28 days; Trifluridine/tipiracil: taken at a recommended dose (based on the results of the safety run-in phase) each time orally twice a day on days 1-5 and 8-12, every 28 days.
DRUG	Bevacizumab combined with trifluridine/tipiracil	Active Comparator: Bevacizumab: 5 mg /kg, intravenously on days 1,15, every 28 days; Trifluridine/tipiracil: 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days.

Timeline

• Start date: 2025-12-31
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-12-16
• Last updated: 2026-01-21

Locations

1 site across 1 country: China