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

Phase 2

Recruiting

• Conditions: Progression-Free Survival
• Interventions: Drug: Metformin Pill; Drug: FOLFIRI plus target therapy only

• Registration Number: NCT06826092
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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

Study Timeline

• Study Start: 2022-10-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Aged between 20 and 90 years old
2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
3. Female must not be planning to become pregnant or breastfeeding, and not pregnant at any point during treatment. (Contraception is required to participate in this trial)
4. Those without major physiological diseases (example of major cardiovascular disease is acute myocardial infarction; example of major cerebrovascular disease is acute stroke, malignant hypertension, acute kidney failure, acute liver failure)
5. Those who are not allergic to the relevant drugs required for the test
6. Those who can follow the doctor's order to take the medicine
7. Subjects must be willing to sign the consent form
8. Blood sugar level above 80 mg/dL

Exclusion Criteria

Subjects who meet any of the following exclusion conditions are not allowed to join the trial

1. Patients other than the above-mentioned main inclusion criteria.

2. Non-native speakers

3. Known allergy to metformin or any of its components.

4. Severe instability in diabetes (ketoacidosis).

5. Blood sugar level lower than 80 mg/dL

6. Heart failure, respiratory insufficiency.

7. inadequate hematopoietic function defined as below:

   • hemoglobin < 9 g/dL;
   • absolute neutrophil count (ANC) < 1,500/mm3;
   • platelet count < 100,000/mm3;

8. inadequate organ functions defined as below:

   • total bilirubin > 2 times upper limit of normal (ULN);
   • hepatic transaminases (ALT and AST) > 2.5 x ULN;
   • creatinine > 1.5 x ULN;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Metformin Pill	Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy
Control group	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

Primary Outcome Measures

Name	Time	Method
Disease progression-free survival (PFS)	The trial will continue to follow (approximately every 4 weeks) the subject's survival status until death, loss of follow-up, end of trial, or termination of the trial, assessed up to 52 months	Disease progression-free survival (PFS) was defined as the date from the initiation of trial treatment until the date of the first imaging-confirmed progression or death (whichever occurred first)

Trial Locations

Locations (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University: 🇨🇳 Kaohsiung, Taiwan