RecruitingPhase 2NCT06826092

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


Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Enrollment

110 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding metformin (a common diabetes drug that may also have anti-cancer effects) to standard chemotherapy (FOLFOX — a combination of leucovorin, fluorouracil, and oxaliplatin) can improve outcomes in people with metastatic colorectal cancer (bowel cancer that has spread). **You may be eligible if...** - You are 18 or older - You have metastatic colorectal cancer (stage IV) - You are starting or continuing FOLFOX chemotherapy - You do not have diabetes or are not currently taking metformin - Your kidneys are functioning well enough to take metformin **You may NOT be eligible if...** - You have significant kidney disease (metformin can be harmful) - You have already tried many lines of chemotherapy - You have a contraindication to metformin (such as severe liver disease or alcohol use) - You are pregnant or breastfeeding - You have a recent history of lactic acidosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin Pill

Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy

DRUGFOLFIRI 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


Locations(1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, Taiwan

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NCT06826092


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