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

Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy

Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy (NCT06826092) is a Phase 2 interventional studying Progression-Free Survival, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Progression-Free Survival and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Progression-Free Survival subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. inyour organs (liver, kidneys, etc.) are working well enough based on blood testss 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; Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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;

Treatments Being Tested

DRUG

Metformin Pill

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

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06826092), the sponsor (Kaohsiung Medical University Chung-Ho Memorial Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06826092 clinical trial studying?

To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06826092?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06826092?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06826092. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06826092. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.