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NCT06826092RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
110 (estimated)
First submitted
27 Jan 2025
Start date
31 Oct 2022
Primary completion date
31 Dec 2025
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
NCT number
NCT06826092

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 110
  • From 31 Oct 2022 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects who meet any of the following exclusion conditions are not allowed to join the trial
  • Known allergy to metformin or any of its components.
  • Severe instability in diabetes (ketoacidosis).
  • Heart failure, respiratory insufficiency.

Lab values

  • Blood sugar level lower than 80 mg/dL
  • inadequate hematopoietic function defined as below:
    • hemoglobin \< 9 g/dL;
    • absolute neutrophil count (ANC) \< 1,500/mm3;
    • platelet count \< 100,000/mm3;
  • 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;

Other

  • Patients other than the above-mentioned main inclusion criteria.
  • Non-native speakers

Who the study is looking for

  • 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)
  • Those who are not allergic to the relevant drugs required for the test
  • Those who can follow the doctor's order to take the medicine
  • Subjects must be willing to sign the consent form
  • Blood sugar level above 80 mg/dL

Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.