NCT07071844

BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients

BEvacizumab Plus Trifluridine/Tipiracil in a Bi-WEEkly Administration to Reduce Grade 3-4 Neutropenia in Patients With mCRC: A Prospective, Multicenter, Comparative, Randomized GERCOR G-124 BETWEEN Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was design to: * To assess the impact of a biweekly (experimental arm) compared to a conventional administration (control arm) on the rate of grade 3-4 neutropenia in metastatic colorectal cancer (mCRC) patients treated with trifluridine/tipiracil plus bevacizumab, and * To identify predictive clinical and biological factors for grade 3-4 neutropenia in this patient population.

Detailed description

Trifluridine/tipiracil is effective in refractory metastatic colorectal cancer (mCRC), as shown in phase III trials, including SUNLIGHT, which demonstrated improved PFS and OS when combined with bevacizumab, setting a new third-line standard. However, this combination raises grade 3-4 neutropenia rates to 43-66%, often leading to dose reductions or delays. A biweekly regimen tested in a small phase II trial showed reduced neutropenia (15.9%) but limited generalizability. Neutropenia remains a major concern, with 9.5% mortality. G-CSF may help manage risk, especially in high-risk patients (LONGBOARD).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/tipiracil	35 mg/m², orally
DRUG	Bevacizumab	5 mg/kg, intravenous route

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

10 sites across 1 country: France