NCT06826092 Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy
| NCT ID | NCT06826092 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Condition | Progression-Free Survival |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2022-10-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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;
Frequently Asked Questions
Who can join the NCT06826092 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Progression-Free Survival. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06826092 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06826092 currently recruiting?
Yes, NCT06826092 is actively recruiting participants. Visit ClinicalTrials.gov or contact Kaohsiung Medical University Chung-Ho Memorial Hospital to inquire about joining.
Where is the NCT06826092 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT06826092 clinical trial?
NCT06826092 is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. The trial plans to enroll 110 participants.