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

NCT06826092 | Recruiting Phase 2

• 1 other identifier: KMUHIRB-F(I)-20220106
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Progression-Free Survival

Outcome Measures

Primary Outcomes (1)

• Disease progression-free survival (PFS)

  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)

  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

Study Arms (2)

Study group

EXPERIMENTAL

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

Drug: Metformin Pill

Control group

PLACEBO COMPARATOR

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

Drug: FOLFIRI plus target therapy only

Interventions

Metformin Pill DRUG

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

Also known as: Glucophage

Study group

FOLFIRI plus target therapy only DRUG

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

Control group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 20 and 90 years old
• Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
• 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)
• 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)
• Those who are not allergic to the relevant drugs required for the test
• Those who can follow the doctor's order to take the medicine
• Subjects must be willing to sign the consent form
• Blood sugar level above 80 mg/dL

You may not qualify if:

• Non-native speakers
• Known allergy to metformin or any of its components.
• Severe instability in diabetes (ketoacidosis).
• Blood sugar level lower than 80 mg/dL
• Heart failure, respiratory insufficiency.
• inadequate hematopoietic function defined as below:
• hemoglobin \< 9 g/dL;
• absolute neutrophil count (ANC) \< 1,500/mm3;
• platelet count \< 100,000/mm3;
• 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;

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 13, 2025
• Study Start: October 31, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)