OncoMatch/Clinical Trials/NCT06887218
5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
Is NCT06887218 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Regorafenib (BAY 73-4506) and 5FU/LV for metastatic colorectal cancer (crc).
Treatment: Regorafenib (BAY 73-4506) · 5FU/LV · Bevacizumab · Trifluridine-tipiracil — This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab. Arm 1 (Treatment Arm) will consist of the 5FU/LV administered to 38 patients as (LV \[400 mg/m² IV over 120 minutes\], followed by 5FU \[400 mg/m² IV bolus then 2400 mg/m² IV infusion over 46 hours\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on /1 week off until disease progression, up to 12 cycles of treatment. Arm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg/m2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
metastatic CRC; A minimum of one measurable disease per RECISTv1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Platelet count ≥100000 /mm3, hemoglobin (Hb) ≥9 g/dL, ANC ≥1500/mm3; INR/PTT ≤ 1.5 x ULN (anticoagulated patients allowed if within therapeutic limits)
Kidney function
Serum creatinine ≤ 1.5 x ULN; estimated glomerular filtration rate ≥ 50 mL/min
Liver function
Total bilirubin ≤ 10 x ULN; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN with liver involvement); alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN with liver involvement)
Cardiac function
No clinically significant and/or uncontrolled cardiac-related abnormality (arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, symptomatic congestive heart failure NYHA III/IV, unstable angina); no myocardial infarction within past 6 months
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: ... see full criteria for details
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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