Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT04616495
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2020-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'five year overall survival (OS)', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'one year disease free survival (DFS)', 'timeFrame': '1 year'}, {'measure': 'three year disease free survival (DFS)', 'timeFrame': '3 years'}, {'measure': 'five year disease free survival (DFS)', 'timeFrame': '5 years'}, {'measure': 'Quality of life using EORTC questionnaires: QLQ-C30', 'timeFrame': '1 year'}, {'measure': 'Quality of life using EORTC questionnaires: QLQ-C30', 'timeFrame': '3 years'}, {'measure': 'Quality of life using EORTC questionnaires: QLQ-C30', 'timeFrame': '5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Metastatic Liver Cancer', 'Liver Metastases']}, 'descriptionModule': {'briefSummary': 'Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 and ≤ years\n* Good performance status, ECOG 0 or 1\n* Resected adenocarcinoma in colon or rectum (R0 resection)\n* Unresectable liver metastases\n* No extrahepatic disease\n* Normal blood tests\n* Response to ≤ 2 lines of chemotherapy (RECIST criteria)\n* ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list\n* Signed informed consent\n\nExclusion Criteria:\n\n* Body mass index ≥ 30\n* Positive HIV or HCV\n* Pregnancy at the time of inclusion\n* BRAF mutated status\n* Deterioration of general condition (10% weight loss in the prior 6 months)\n* Other malignancy with disease free survival \\< 5 years\n* Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.\n* Palliative resection of primary colorectal adenocarcinoma\n* Liver metastases size \\> 5 cm (in the last imaging technique)\n* CEA \\> 80 ng/ml (at time of enrolment in waiting list)\n* No neoadjuvant chemotherapy treatment\n* General contraindication to liver transplantation'}, 'identificationModule': {'nctId': 'NCT04616495', 'acronym': 'TRASMETIR', 'briefTitle': 'Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Fe'}, 'officialTitle': 'Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases', 'orgStudyIdInfo': {'id': 'TRASMETIR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplanted patients', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Chemotherapy and liver transplantation', 'armGroupLabels': ['Liver transplanted patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eva M Montalvá, PhD', 'role': 'CONTACT', 'email': 'montalva.oron@gmail.com', 'phone': '+34961245858'}], 'facility': 'Eva M Montalvá', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Eva M Montalvá, PhD', 'role': 'CONTACT', 'email': 'montalva.oron@gmail.com', 'phone': '+34961245858'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hepatobiliarypancreatic and Transplant Surgeon', 'investigatorFullName': 'Eva M. Montalvá', 'investigatorAffiliation': 'Hospital Universitario La Fe'}}}}