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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

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Progression-Free Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Metformin Pill

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

FOLFIRI plus target therapy only

Intervention Type 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

Interventions

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Metformin Pill

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Glucophage

Eligibility Criteria

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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

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;