Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-28 @ 5:07 PM
Study NCT ID:
NCT06826092
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression-free survival (PFS)', 'timeFrame': "The trial will continue to follow (approximately every 4 weeks) the subject's survival status until death, loss of follow-up, end of trial, or termination of the trial, assessed up to 52 months", 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progression-Free Survival']}, 'descriptionModule': {'briefSummary': 'To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin', 'detailedDescription': 'Objectives:\n\n1. Main purpose\n\n • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin\n2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged between 20 and 90 years old\n2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy\n3. 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)\n4. 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)\n5. Those who are not allergic to the relevant drugs required for the test\n6. Those who can follow the doctor's order to take the medicine\n7. Subjects must be willing to sign the consent form\n8. Blood sugar level above 80 mg/dL\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion conditions are not allowed to join the trial\n\n1. Patients other than the above-mentioned main inclusion criteria.\n2. Non-native speakers\n3. Known allergy to metformin or any of its components.\n4. Severe instability in diabetes (ketoacidosis).\n5. Blood sugar level lower than 80 mg/dL\n6. Heart failure, respiratory insufficiency.\n7. inadequate hematopoietic function defined as below:\n\n * hemoglobin \\< 9 g/dL;\n * absolute neutrophil count (ANC) \\< 1,500/mm3;\n * platelet count \\< 100,000/mm3;\n8. inadequate organ functions defined as below:\n\n * total bilirubin \\> 2 times upper limit of normal (ULN);\n * hepatic transaminases (ALT and AST) \\> 2.5 x ULN;\n * creatinine \\> 1.5 x ULN;"}, 'identificationModule': {'nctId': 'NCT06826092', 'briefTitle': 'Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(I)-20220106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy', 'interventionNames': ['Drug: Metformin Pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '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', 'interventionNames': ['Drug: FOLFIRI plus target therapy only']}], 'interventions': [{'name': 'Metformin Pill', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy', 'armGroupLabels': ['Study group']}, {'name': 'FOLFIRI plus target therapy only', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jaw-Yuan Wang, PhD', 'role': 'CONTACT', 'email': 'cy614112@ms14.hinet.net', 'phone': '+88673121101', 'phoneExt': '5575'}, {'name': 'Wei-Chih Su, MS', 'role': 'CONTACT', 'email': 'lake0126@yahoo.com.tw', 'phone': '+88673121101', 'phoneExt': '5575'}, {'name': 'Jaw-Yuan Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jaw-Yuan Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ho Memorial Hospital, Kaohsiung Medical University:', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared. Results will be published by the investigators in academic journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jaw-Yuan Wang, MD, PhD', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}