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OncoMatch/Clinical Trials/NCT07011576

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

Is NCT07011576 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including fruquintinib and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) for colon cancer.

Phase 2RecruitingSCRI Development Innovations, LLCNCT07011576Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: BRAF V600

Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600

Excluded: MSH2 microsatellite instability high

Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: platinum-based chemotherapy (FOLFOX) — first-line

Participants must have received FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab-based first-line therapy for mCRC

Must have received: VEGF inhibitor (bevacizumab) — first-line

Participants must have received FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab-based first-line therapy for mCRC

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 →

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