Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03518502
Status:
UNKNOWN
Last Update Posted:
2018-05-08
First Post:
2018-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sorafenib monotherapy vs. transarterial chemoembolization-sorafenib sequential therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-06', 'studyFirstSubmitDate': '2018-04-21', 'studyFirstSubmitQcDate': '2018-05-06', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)', 'description': 'Survival rate during the study period'}], 'secondaryOutcomes': [{'measure': 'Time to progression (TTP)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)', 'description': 'Time form the enrollment to the event of progression'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)', 'description': 'Survival rate without progression of HCC'}, {'measure': 'Median survival time (MST)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)', 'description': 'Median time of the patient survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Metastasis']}, 'referencesModule': {'references': [{'pmid': '12049862', 'type': 'RESULT', 'citation': 'Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.'}, {'pmid': '11981766', 'type': 'RESULT', 'citation': 'Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.'}, {'pmid': '12091661', 'type': 'RESULT', 'citation': 'Camma C, Schepis F, Orlando A, Albanese M, Shahied L, Trevisani F, Andreone P, Craxi A, Cottone M. Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials. Radiology. 2002 Jul;224(1):47-54. doi: 10.1148/radiol.2241011262.'}, {'pmid': '12540794', 'type': 'RESULT', 'citation': 'Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.'}, {'pmid': '18650514', 'type': 'RESULT', 'citation': 'Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.'}, {'pmid': '19095497', 'type': 'RESULT', 'citation': 'Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.'}, {'pmid': '21605146', 'type': 'RESULT', 'citation': 'Cabrera R, Pannu DS, Caridi J, Firpi RJ, Soldevila-Pico C, Morelli G, Clark V, Suman A, George TJ Jr, Nelson DR. The combination of sorafenib with transarterial chemoembolisation for hepatocellular carcinoma. Aliment Pharmacol Ther. 2011 Jul;34(2):205-13. doi: 10.1111/j.1365-2036.2011.04697.x. Epub 2011 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.', 'detailedDescription': 'Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, transarterial chemoembolization (TACE) which is a standard therapy for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby providing chance of improving survival in HCC patients with EHM.\n\nThe investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.\n\nThis study is a prospective randomized controlled study being conducted at 6 tertiary hospitals in South Korea. HCC patients with EHM are being enrolled and randomized into sorafenib monotherapy or TACE-sorafenib sequential therapy group. Patients with main portal vein invasion, Child-Pugh class B or C, and history of TACE or previous systemic therapy are being excluded. The sorafenib monotherapy group receives sorafenib immediately after randomization while the TACE-sorafenib group receives 2\\~4 times of TACE before starting sorafenib. Response evaluation are performed every 2 months, and time to progression (TTP), progression free survival (PFS), median survival time (MST), and overall survival (OS) which is the primary outcome measure will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology\n* One or more extrahepatic metastatic lesion by proven radiologically or histologically\n* No serious coagulation abnormalities\n* Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria\n* Child-Pugh score 5 or 6\n* Serum creatinine \\<1.5mg/dL\n* Age between 18 \\~ 75 years old\n* No other life-threatening medical illness\n\nExclusion Criteria:\n\n* Patients with main portal vein invasion\n* Child-Pugh class B or C\n* History of TACE or previous systemic chemotherapy including sorafenib\n* Age \\>75 years old\n* Cardiovascular diseases\n* History of gastrointestinal bleeding within 2 weeks'}, 'identificationModule': {'nctId': 'NCT03518502', 'briefTitle': 'Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis', 'orgStudyIdInfo': {'id': '2012AS0313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sorafenib monotherapy arm', 'description': 'The sorafenib monotherapy group receives sorafenib immediately after randomization.', 'interventionNames': ['Drug: Sorafenib']}, {'type': 'EXPERIMENTAL', 'label': 'TACE-sorafenib sequential therapy arm', 'description': 'TACE(transarterial chemoembolization )-sorafenib group receives 2\\~4 times of TACE before starting sorafenib.', 'interventionNames': ['Procedure: transarterial chemoembolization (TACE)', 'Drug: Sorafenib']}], 'interventions': [{'name': 'transarterial chemoembolization (TACE)', 'type': 'PROCEDURE', 'description': 'Standard therapy for intermediate HCC, but nor for advanced HCC', 'armGroupLabels': ['TACE-sorafenib sequential therapy arm']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Standard therapy for advanced HCC', 'armGroupLabels': ['Sorafenib monotherapy arm', 'TACE-sorafenib sequential therapy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '425-707', 'city': 'Ansan', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung Joon Yim, M.D.', 'role': 'CONTACT', 'email': 'gudwns21@korea.ac.kr', 'phone': '82-31-412-6565'}, {'name': 'Sang Jun Suh, M.D.', 'role': 'CONTACT', 'email': 'mothpickle@naver.com', 'phone': '82-31-412-4926'}, {'name': 'Hyung Joon Yim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sang Jun Suh, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Kul Jung, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.21795, 'lon': 127.55845}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Seok Kim', 'role': 'CONTACT'}], 'facility': 'Soonchunghyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Jin Chung', 'role': 'CONTACT'}], 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Bum Cho, M.D.', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hwasoon Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Si-Hyun Bae', 'role': 'CONTACT'}], 'facility': 'Seoul Saint Marry Hospital, the Catholic University of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun Yong Park, M.D.', 'role': 'CONTACT'}], 'facility': 'Severance Hospital, Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyung Joon Yim, M.D.', 'role': 'CONTACT', 'email': 'gudwns21@korea.ac.kr', 'phone': '82-31-412-6565'}], 'overallOfficials': [{'name': 'Hyung Joon Yim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Ansan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Liver Cancer Study Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung Joon Yim', 'investigatorAffiliation': 'Korea University'}}}}