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Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Feb 2026 to Jan 27, 2026v5
  2. Start date: Dec 2025 to Feb 2026v4
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 2025 to Dec 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Aug 2025 to Dec 2025
    • Site details revised
  4. Eligibility criteria expanded, about 9 words Secondary endpoints revised (2) · Study description expanded, about 1 word · Study title shortened, about 2 wordsv2 Show 3 more changesShow less
    • Secondary endpoints revised (2)
    • Study description expanded, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.
Trial Details
NCT Number NCT07042685
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Takeda Development Center Americas, Inc.
Conditions Metastatic Colorectal Cancer (CRC)
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov