5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

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 admin

Trial Details

NCT ID

NCT06887218

Phase

PHASE2

Sponsor

The Methodist Hospital Research Institute

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

• Regorafenib (BAY 73-4506)
• 5FU/LV
• Bevacizumab
• Trifluridine-tipiracil

Locations (sample)

• Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

• Male or female ≥18 years of age.
• Histopathological or cytologically confirmed metastatic CRC.
• Failed second-line therapy for metastatic disease.
• A minimum of one measurable disease per RECISTv1.1.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →