Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 6:28 AM
Study NCT ID:
NCT04874259
Status:
RECRUITING
Last Update Posted:
2022-09-06
First Post:
2021-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LT for Unresectable Colorectal Liver Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2021-05-02', 'studyFirstSubmitQcDate': '2021-05-02', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 year patient survival', 'timeFrame': '1 year', 'description': '1 year patient survival'}], 'secondaryOutcomes': [{'measure': '1 year disease-free survival', 'timeFrame': '1 year', 'description': '1 year disease-free survival'}, {'measure': '3 year patient survival', 'timeFrame': '3 year', 'description': '3 year patient survival'}, {'measure': '3 year disease-free survival', 'timeFrame': '3 year', 'description': '3 year disease-free survival'}, {'measure': 'Recurrence', 'timeFrame': '3 year', 'description': 'Site and pattern of recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'liver metastasis', 'living donor liver transplantation'], 'conditions': ['Liver Metastasis Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '11775446', 'type': 'BACKGROUND', 'citation': 'Koffron A, Fryer JP, Abecassis M. Indications and results of liver transplantation for primary and metastatic liver cancer. Cancer Treat Res. 2001;109:77-99. doi: 10.1007/978-1-4757-3371-6_5. No abstract available.'}, {'pmid': '12802483', 'type': 'BACKGROUND', 'citation': 'Honore C, Detry O, De Roover A, Meurisse M, Honore P. Liver transplantation for metastatic colon adenocarcinoma: report of a case with 10 years of follow-up without recurrence. Transpl Int. 2003 Sep;16(9):692-3. doi: 10.1007/s00147-003-0605-3. Epub 2003 Jun 12.'}, {'pmid': '16421478', 'type': 'BACKGROUND', 'citation': 'Kappel S, Kandioler D, Steininger R, Langle F, Wrba F, Ploder M, Berlakovich G, Soliman T, Hetz H, Rockenschaub S, Roth E, Muhlbacher F. Genetic detection of lymph node micrometastases: a selection criterion for liver transplantation in patients with liver metastases after colorectal cancer. Transplantation. 2006 Jan 15;81(1):64-70. doi: 10.1097/01.tp.0000189711.98971.9c.'}, {'pmid': '19470929', 'type': 'BACKGROUND', 'citation': 'Kopetz S, Chang GJ, Overman MJ, Eng C, Sargent DJ, Larson DW, Grothey A, Vauthey JN, Nagorney DM, McWilliams RR. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009 Aug 1;27(22):3677-83. doi: 10.1200/JCO.2008.20.5278. Epub 2009 May 26.'}, {'pmid': '17925551', 'type': 'BACKGROUND', 'citation': "Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, Kemeny N, Brennan MF, Blumgart LH, D'Angelica M. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007 Oct 10;25(29):4575-80. doi: 10.1200/JCO.2007.11.0833."}, {'pmid': '23360920', 'type': 'BACKGROUND', 'citation': 'Hagness M, Foss A, Line PD, Scholz T, Jorgensen PF, Fosby B, Boberg KM, Mathisen O, Gladhaug IP, Egge TS, Solberg S, Hausken J, Dueland S. Liver transplantation for nonresectable liver metastases from colorectal cancer. Ann Surg. 2013 May;257(5):800-6. doi: 10.1097/SLA.0b013e3182823957.'}, {'pmid': '25297902', 'type': 'BACKGROUND', 'citation': 'Dueland S, Hagness M, Line PD, Guren TK, Tveit KM, Foss A. Is Liver Transplantation an Option in Colorectal Cancer Patients with Nonresectable Liver Metastases and Progression on All Lines of Standard Chemotherapy? Ann Surg Oncol. 2015 Jul;22(7):2195-200. doi: 10.1245/s10434-014-4137-0. Epub 2014 Oct 9.'}, {'pmid': '29532908', 'type': 'BACKGROUND', 'citation': 'Dueland S, Foss A, Solheim JM, Hagness M, Line PD. Survival following liver transplantation for liver-only colorectal metastases compared with hepatocellular carcinoma. Br J Surg. 2018 May;105(6):736-742. doi: 10.1002/bjs.10769. Epub 2018 Mar 13.'}, {'pmid': '30839338', 'type': 'BACKGROUND', 'citation': "Simoneau E, D'Angelica M, Halazun KJ. Liver transplantation for colorectal liver metastasis. Curr Opin Organ Transplant. 2019 Apr;24(2):175-181. doi: 10.1097/MOT.0000000000000623."}, {'pmid': '28544246', 'type': 'BACKGROUND', 'citation': 'Toso C, Pinto Marques H, Andres A, Castro Sousa F, Adam R, Kalil A, Clavien PA, Furtado E, Barroso E, Bismuth H; Compagnons Hepato-Biliaires Group. Liver transplantation for colorectal liver metastasis: Survival without recurrence can be achieved. Liver Transpl. 2017 Aug;23(8):1073-1076. doi: 10.1002/lt.24791. No abstract available.'}, {'pmid': '32333096', 'type': 'BACKGROUND', 'citation': 'Glinka J, Ardiles V, Pekolj J, Mattera J, Sanchez Claria R, de Santibanes E, de Santibanes M. Liver transplantation for non-resectable colorectal liver metastasis: where we are and where we are going. Langenbecks Arch Surg. 2020 May;405(3):255-264. doi: 10.1007/s00423-020-01883-2. Epub 2020 Apr 24.'}, {'pmid': '31674105', 'type': 'BACKGROUND', 'citation': 'Dueland S, Grut H, Syversveen T, Hagness M, Line PD. Selection criteria related to long-term survival following liver transplantation for colorectal liver metastasis. Am J Transplant. 2020 Feb;20(2):530-537. doi: 10.1111/ajt.15682. Epub 2019 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. However, due to progressive development in treatments, good results such as increased survival rates can be expected even in liver transplant patients with liver metastasis from colorectal cancer, which is known to have poor prognosis. Therefore, the purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.', 'detailedDescription': 'Surgical treatment offers a distinct survival benefit in liver metastasis of colorectal cancer (CRC LM). However, it has been estimated that only 40% of patients are candidates for curative liver resection. Liver transplantation can be considered as one of a treatment option, since all evident disease is removed during procedure. However, it is limited in only few centers due to lack of organs and high recurrence rates after transplantation.\n\nCurrently, with help of development in treatments, prognosis after LT in CRC LM is improving. Recent study of LT for CRC LM from Norway demonstrated a 5-year survival of 56%. In addition, cohort study and randomized controlled trials are ongoing in Germany and Canada. Therefore, it seems to be necessary to verify the effectiveness of liver transplantation for CRC LM and to verify it as an alternative treatment if there is no other treatment. The purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.\n\nPotential participants will be evaluated for liver transplantation and must also have a willing, healthy living donor. Unresectable metastasis should be limited to the liver and stable without no other treatment such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation. The suitability of liver transplantation will be evaluated through a multidisciplinary assessment immediately before transplantation. Those participants who undergo liver transplantation will be followed for survival, disease-free survival, and recurrence for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven colorectal cancer liver metastases without no other treatment (such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation)\n* Metastasis isolated to liver\n* Patients selected as a liver transplant recipient at a multidisciplinary meeting\n* Paitents with a willing, healthy living donor\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Known history of human immunodeficiency virus (HIV) infection\n* Patients with active peptic ulcer within 2 weeks of transplantation\n* Persistent colorectal cancer after colon resection\n* Hemodynamically unstable prior to liver transplantation\n* Progression of LM at any timepoint prior to transplant surgery (assessed in a multidisciplinary meeting)'}, 'identificationModule': {'nctId': 'NCT04874259', 'briefTitle': 'LT for Unresectable Colorectal Liver Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study', 'orgStudyIdInfo': {'id': '209-176-1162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colorectal cancer liver metastasis', 'description': 'Liver transplantation for the treatment of unresectable colorectal cancer liver metastasis', 'interventionNames': ['Procedure: Living donor liver transplantation']}], 'interventions': [{'name': 'Living donor liver transplantation', 'type': 'PROCEDURE', 'description': 'Living donor liver transplantation', 'armGroupLabels': ['Colorectal cancer liver metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'YoungRok Choi, M.D.', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'YoungRok Choi, MD', 'role': 'CONTACT', 'email': 'choiyoungrok@gmail.com', 'phone': '82-2072-0069'}], 'overallOfficials': [{'name': 'Nam-Joon Yi, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nam-Joon Yi', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}