OncoMatch/Clinical Trials/NCT07011576
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
Is NCT07011576 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including fruquintinib and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) for colon cancer.
Treatment: fruquintinib · FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) — This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: BRAF v600
BRAF V600
Excluded: MSI high
microsatellite instability high (MSI-H)
Disease stage
Required: Stage IV
Metastatic disease required
Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy (oxaliplatin, fluoropyrimidine, bevacizumab) — first-line therapy for metastatic colorectal cancer
Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. A minimum of 2 cycles of first line of therapy must have been completed.
Cannot have received: systemic therapy for metastatic colorectal cancer
More than one prior systemic treatment for mCRC
Cannot have received: FOLFIRI or irinotecan-based therapy (FOLFIRI, irinotecan)
any prior systemic treatment including FOLFIRI or irinotecan-based therapy
Cannot have received: systemic therapy in neoadjuvant or adjuvant setting (oxaliplatin, fluoropyrimidine)
Exception: progressed within 6 months (due to lack of BEV exposure)
Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rocky Mountain Cancer Center - Primary · Denver, Colorado
- Illinois Cancer Specialists · Arlington Heights, Illinois
- Maryland Oncology Hematology · Columbia, Maryland
- Minnesota Oncology Hematology - Primary · Maple Grove, Minnesota
- Missouri Cancer Associates · Columbia, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07011576 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for metastatic colorectal cancer, FOLFIRI or irinotecan-based therapy, systemic therapy in neoadjuvant or adjuvant setting disqualifies patients from enrollment.
Are patients with BRAF alterations eligible?
No. BRAF v600 is an exclusion criterion.
Are patients with MSI alterations eligible?
No. MSI high is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages