OncoMatch/Clinical Trials/NCT07042685
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
Is NCT07042685 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fruquintinib Combined With Chemotherapy for metastatic colorectal cancer (crc).
Treatment: Fruquintinib Combined With Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: BRAF mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count ≤1500 cells/mm3. Platelets ≤100,000 cells/mm3. Hemoglobin ≤9 g/dL. White blood count ≤3000 cells/mm3.
Kidney function
Serum creatinine or serum urea >1.5 × ULN. Estimated glomerular filtration rate <50 mL/min. Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h.
Liver function
AST or ALT >5 × ULN if hepatic metastases; >2.5 × ULN if no liver metastases. Total bilirubin >1.7 mg/dL × ULN. Serum albumin <2.8 g/dL.
Cardiac function
No clinically significant and/or uncontrolled cardiac-related abnormality (arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, symptomatic congestive heart failure NYHA Class III or IV, unstable angina pectoris). No myocardial infarction within the past 6 months.
Hematology laboratory values of: Absolute neutrophil count ≤1500 cells/mm3; Platelets ≤100,000 cells/mm3; Hemoglobin ≤9 g/dL; White blood count ≤3000 cells/mm3. Hepatic laboratory values of AST or ALT >5 × ULN if hepatic metastases; >2.5 × ULN if no liver metastases. Serum albumin <2.8 g/dL. Total bilirubin >1.7 mg/dL × ULN. Prothrombin time (PT) or INR >1.5 × ULN. Serum creatinine or serum urea >1.5 × ULN. Estimated glomerular filtration rate <50 mL/min. Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to: Arrhythmia, Bradycardia, Tachycardia, Symptomatic valvular disease, Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV, Unstable angina pectoris. Myocardial infarction within the past 6 months from consent.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Methodist Neal Cancer Center · Houston, Texas
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