Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-04-09 @ 12:16 PM
Study NCT ID:
NCT00817895
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2009-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2009-01-04', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'liver resection', 'intraoperative chemotherapy'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': "Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor \\>5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.", 'detailedDescription': "150 HCC patients with tumor \\>5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. tumor \\>5cm;\n2. multiple tumor located in one liver lobe;\n3. margin of tumor is not clear;\n4. cutting edge to tumor \\<1cm;\n5. portal vein branch invasion;\n6. without extra-liver metastasis;\n7. patient's liver function and condition is able to accept hepatectomy.\n\nExclusion Criteria:\n\n1. single tumor \\<=5cm;\n2. multiple tumor located more than in one liver lobe;\n3. margin of tumor is clear;\n4. cutting edge to tumor \\>=1cm;\n5. portal vein stem invasion\n6. extra-liver metastasis;\n7. patient's liver function and condition cannot accept hepatectomy."}, 'identificationModule': {'nctId': 'NCT00817895', 'briefTitle': 'Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence', 'orgStudyIdInfo': {'id': 'EHBH-RCT-2008-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-FU+Cisplatin', 'description': '50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.', 'interventionNames': ['Drug: sustained released 5-FU and sustained released cisplatin', 'Procedure: TACE']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5-FU', 'description': '50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.', 'interventionNames': ['Drug: sustained released 5-FU', 'Procedure: TACE']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'interventionNames': ['Procedure: TACE']}], 'interventions': [{'name': 'sustained released 5-FU and sustained released cisplatin', 'type': 'DRUG', 'otherNames': ['5-FU+Cisplatin group'], 'description': '600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.', 'armGroupLabels': ['5-FU+Cisplatin']}, {'name': 'sustained released 5-FU', 'type': 'DRUG', 'otherNames': ['5-FU group'], 'description': '600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.', 'armGroupLabels': ['5-FU']}, {'name': 'TACE', 'type': 'PROCEDURE', 'otherNames': ['Postoperative TACE'], 'description': 'All patients will accept TACE one month after tumor was resected.', 'armGroupLabels': ['5-FU', '5-FU+Cisplatin', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shen Feng, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}]}, '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'}}}}