About this trial
To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients other than the above-mentioned main inclusion criteria.
Non-native speakers
Known allergy to metformin or any of its components.
Severe instability in diabetes (ketoacidosis).
Trial design
Parallel
Treatments tested in this trial
Metformin Pill
DrugMetformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy
FOLFIRI plus target therapy only
DrugFOLFIRI (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
Treatment groups
Trial outcomes
Primary outcomes
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)
Sponsors and contacts
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