Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00834158
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2009-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2009-01-31', 'studyFirstSubmitQcDate': '2009-01-31', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of tumor resection after intervention', 'timeFrame': '1 to 2 months'}], 'secondaryOutcomes': [{'measure': 'rate of survival', 'timeFrame': '1, 3, 5 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Hepatitis B', 'Transarterial chemoembolization (TACE)', 'Portal vein embolization (PVE)', 'Surgical resection', 'Disease-free survival', 'Overall survival'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.', 'detailedDescription': 'In China, primary hepatocellular carcinoma (HCC) is mostly a hepatitis B related disease. The liver function of these patients has been damaged, which often limit the execution of major hepatectomy. A tumor is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease. In China, TACE is the most common treatment for these unresectable HCC. TACE can slow down tumor progress but has little effect on enlarging FLR. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. But the intrahepatic arterioportal shunt and the tumor progress has decreased the effect of PVE. In order to shut the arterioportal shunt and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age:20-65years old;\n2. with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor;\n3. single lesion with a diameter \\>6.5cm,or multiple lesions locating within half liver or adjacent three lobe;\n4. estimated liver remnant volume ≤40%\n5. with a liver function of Child-Pugh class A,and ALT≤80IU/l.\n\nExclusion criteria:\n\n1. reject to attend；\n2. portal vein trunk has been compressed by tumor;\n3. diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;\n4. with extrahepatic metastasis;\n5. with obvious portal hypertension (with moderate to severe varix in esophagus and/or gastric fundus, enlarged spleen,WBC\\<4×109／L, PLT\\<80×109／L)\n6. with diabetes\n7. allergy to iodine'}, 'identificationModule': {'nctId': 'NCT00834158', 'acronym': 'TACEPVE', 'briefTitle': 'Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'EHBH-RCT-2008-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TACE', 'description': 'perform TACE only', 'interventionNames': ['Procedure: TACE']}, {'type': 'EXPERIMENTAL', 'label': 'TACE+PVE', 'description': 'perform TACE and PVE sequentially', 'interventionNames': ['Procedure: TACE', 'Procedure: PVE']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'otherNames': ['transaterial chemoemblization'], 'description': '1 time', 'armGroupLabels': ['TACE', 'TACE+PVE']}, {'name': 'PVE', 'type': 'PROCEDURE', 'otherNames': ['portal vein embolization'], 'description': '1 time', 'armGroupLabels': ['TACE+PVE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'country': 'China', 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Feng Shen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital, Second Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president of the Eastern Hepatobiliary Surgery Hospotal', 'investigatorFullName': 'ShenFeng', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}}