NCT06787105

Fruquintinib in Patients With Metastatic Colorectal Cancer

Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies. To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib. Participants will be treated as decided by the treating physician and according to their routine practice. FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.

Detailed description

FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib. All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data. The companion translational research project "FRUQUENT FUTURE" aims to identify patient collectives that benefit the most from a therapy with fruquintinib. To this end, archival tumor tissue and whole blood from routine blood draws is collected. Real-world clinical data on effectiveness is correlated with biomarker profiles of tumor tissues to determine biomarkers that are indicative of a response to fruquintinib. Longitudinal monitoring of circulating tumor DNA (ctDNA) will allow for an investigation of ctDNA as an indicator of benefit and response to fruquintinib.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-01-22
• Last updated: 2026-04-06

Locations

1 site across 1 country: Germany