Using Metformin with FOLFIRI chemotherapy for metastatic colorectal cancer
Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy
This study is testing if adding Metformin to FOLFIRI chemotherapy can help people with metastatic colorectal cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06826092 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Metformin in improving progression-free survival (PFS) in patients with metastatic colorectal cancer who are receiving FOLFIRI chemotherapy. Participants will be divided into two groups: one receiving FOLFIRI alone and the other receiving FOLFIRI combined with Metformin. The study also aims to assess overall survival (OS) and disease control rate (DCR) among the participants. The trial will include patients aged 20 to 90 who meet specific health criteria and are willing to adhere to treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 90 diagnosed with metastatic colorectal cancer who are scheduled to receive FOLFIRI chemotherapy.
Not a fit: Patients with significant physiological diseases or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with metastatic colorectal cancer.
How similar studies have performed: While the combination of Metformin with chemotherapy is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Kaohsiung City
- Chung-Ho Memorial Hospital, Kaohsiung Medical University: — Kaohsiung City, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.