Actively Recruiting
Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
Led by iOMEDICO AG · Updated on 2026-04-06
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
iOMEDICO AG
Lead Sponsor
T
Takeda GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well Fruquintinib works in treating adults with metastatic colorectal cancer (mCRC) who have already received standard treatments. The study is observational and collects real-world data from patients in Germany, focusing on how patients respond to Fruquintinib, survival, safety, medical care use, and quality of life. It includes a translational research project to link clinical data with tumor and blood biomarkers to understand which patients benefit most. Participants receive Fruquintinib as prescribed by their doctors according to routine clinical practice. The study plans to recruit about 150 patients across 50 centers, including offices, outpatient oncology centers, and hospitals. Archival tumor tissue and blood samples are collected to study biomarkers, and circulating tumor DNA is monitored over time to assess treatment response. During the study, patients' disease control rates, treatment responses, survival times, adverse events, and quality of life will be measured. Data on treatment duration, modifications, hospital visits, and use of medical care will also be recorded. The study follows participants for up to 33 months, monitoring clinical outcomes and biomarker changes to better understand Fruquintinib's effects in real-world settings.
CONDITIONS
Brief Title
Fruquintinib in Patients With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with metastatic colorectal cancer
- Planned therapy with Fruquintinib as monotherapy according to current German SmPC
- Prior treatment with standard therapies including fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies, anti-VEGF therapy, and if RAS wild-type, anti-EGFR therapy
- Progression on or intolerance to trifluridine/tipiracil and/or regorafenib
- Signed written informed consent
- Patients may be enrolled up to 6 weeks after first Fruquintinib dose (PRO assessments not allowed for these patients)
You will not qualify if you...
- Participation in any interventional clinical trial within 30 days prior to enrollment or treatment start (except follow-up)
- Contraindications to Fruquintinib according to current SmPC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Approximately 6 months
Participants who receive fruquintinib as part of routine clinical care are observed to collect real-world data on treatment effectiveness and safety.
Visits as part of routine clinical practice
Duration - Up to 33 months
Participants are followed for survival outcomes, quality of life, biomarker analysis, and subsequent therapies after fruquintinib treatment ends.
Follow-up visits as per clinical practice
Trial Site Locations
Total: 1 location
1
Onkologische Schwerpunktpraxis
Hanover, Lower Saxony, Germany, 30161
Actively Recruiting
Research Team
M
Max D Mai, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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