NCT06826092

Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy

Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

Detailed description

Objectives: 1. Main purpose • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin 2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

Conditions

• Progression-Free Survival

Interventions

Type	Name	Description
DRUG	Metformin Pill	Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy
DRUG	FOLFIRI plus target therapy only	FOLFIRI (Leucovorin (LV), 200 mg/m2, 2-hour infusion, 5-FU, 2,800 mg/m2, 46-hour infusion, Irinotecan (IRI), 180 mg/m2, 2-hour infusion) plus target therapy

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: Taiwan