NCT07124858

Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.

Detailed description

Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically. Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters. The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib. As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.

Conditions

• Metastatic Colorectal Cancer (CRC)
• Antineoplastic Agents, Immunological
• VEGFR-TKI

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-03-01
• Completion: 2031-12-31
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

83 sites across 1 country: France