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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Colorectal Cancer (CRC); Antineoplastic Agents, Immunological; VEGFR-TKI
• Interventions: Drug: Fruquintinib

• Registration Number: NCT07124858
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2026-03-01
• Primary Completion: 2031-03-01
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients aged 18 and over.
• Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
• Obtain informed consent from the patient for the clinical-biological cohort.
• Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).

Exclusion Criteria

• Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
• Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
• Pregnant or breast-feeding women.
• Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fruquintinib	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.

Primary Outcome Measures

Name	Time	Method
overall survival	up to 1 year after treatment start	OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).

Secondary Outcome Measures

Name	Time	Method
progression free survival	up to 1 year after treatment start	Time (months) from initiation of treatment with fruquintinib to radiological and/or clinical tumour progression or death from any cause.

Trial Locations

Locations (52)

Centre Hospitalier; 🇫🇷 Versailles, France

CHU; 🇫🇷 Vandœuvre-lès-Nancy, France

Clinique de L Europe; 🇫🇷 Amiens, France

Centre Hospitalier Bethune Beuvry; 🇫🇷 Beuvry, France

Centre Pierre Curie; 🇫🇷 Beuvry, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Polynclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Infirmerie Protestante; 🇫🇷 Caluire-et-Cuire, France

Clinique Sainte Marie; 🇫🇷 Chalon-sur-Saône, France

ROC37; 🇫🇷 Chambray-lès-Tours, France

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