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 (Jun 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 The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.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
Treatments studied
Targeted therapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06887218 currently recruiting?
Yes, this trial is currently recruiting patients.
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