Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01125020
Status:
UNKNOWN
Last Update Posted:
2010-05-18
First Post:
2010-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D012008', 'term': 'Recurrence'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumor recurrence and metastasis', 'timeFrame': 'within the first year after liver transplantation', 'description': 'Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy'}], 'secondaryOutcomes': [{'measure': 'Postoperative survival', 'timeFrame': 'within the first year after liver transplantation', 'description': 'Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.'}]}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Hepatocellular Carcinoma', 'Tumor Recurrence and Metastasis', 'Survival', 'Adjuvant Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '19857695', 'type': 'BACKGROUND', 'citation': 'Dudek K, Kornasiewicz O, Remiszewski P, Kobryn K, Ziarkiewicz-Wroblewska B, Gornicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016.'}, {'pmid': '16573544', 'type': 'BACKGROUND', 'citation': 'Soderdahl G, Backman L, Isoniemi H, Cahlin C, Hockerstedt K, Broome U, Makisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94. doi: 10.1111/j.1432-2277.2006.00279.x.'}, {'pmid': '17330837', 'type': 'BACKGROUND', 'citation': 'Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Treatment with other postoperative adjuvant chemotherapy\n* Survival is less than 3 months after liver transplantation\n* Inability to provide written informed consent prior to study entry'}, 'identificationModule': {'nctId': 'NCT01125020', 'briefTitle': 'Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'orgStudyIdInfo': {'id': '2008BAI60B03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gemcitabine and oxaliplatin', 'interventionNames': ['Drug: gemcitabine and oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'doxorubicin, 5-Fu and cisplatin', 'interventionNames': ['Drug: doxorubicin, 5-Fu and cisplatin']}], 'interventions': [{'name': 'gemcitabine and oxaliplatin', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.', 'armGroupLabels': ['gemcitabine and oxaliplatin']}, {'name': 'doxorubicin, 5-Fu and cisplatin', 'type': 'DRUG', 'description': 'Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.', 'armGroupLabels': ['doxorubicin, 5-Fu and cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Hai Peng, MD', 'role': 'CONTACT', 'email': 'pengpzh@hotmail.com', 'phone': '0086-021-63240090', 'phoneExt': '3132'}, {'name': 'Jun-Wei Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jun-Yi Wu, MM', 'role': 'CONTACT', 'email': 'wjy8541@126.com', 'phone': '0086-021-63240090', 'phoneExt': '3136'}], 'overallOfficials': [{'name': 'Zhi-Hai Peng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': "Shanghai First People's Hosptial"}}}}