Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT00518557
Status:
UNKNOWN
Last Update Posted:
2009-01-22
First Post:
2007-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], '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': '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-21', 'studyFirstSubmitDate': '2007-08-16', 'studyFirstSubmitQcDate': '2007-08-17', 'lastUpdatePostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability, Mortality', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver cancer', 'interventional radiology', 'Chemoembolization', 'Safety', 'Effectiveness'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cytologically or histologically documented HCC, who are candidates for TACE\n* Child-Pugh Child A or B\n* Age \\>= 18\n* Measurable disease by RECIST criteria;\n* Performance status ECOG 0-2\n* Previous local therapy completed \\> 4 weeks\n* Written informed consent signed\n* Normal organ and marrow function defined as:\n\nHaematopoietic:\n\n* WBC ≥ 3,000/µlplatelet count \\> 80,000/mm3\n* haemoglobin \\> 9g/dL\n* Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \\< 5 x ULN\n* Renal: creatinine \\< 1.5 x ULN\n\nExclusion Criteria:\n\n* Metastases\n* Prior or concomitant chemotherapy or radiation therapy\n* VEGF/VEGFR- inhibitors or other anti-angiogenesis agents\n* Severe and/or uncontrolled medical conditions:\n* Congestive heart failure, serious cardiac arrhythmia, active coronary artery\n* Severe renal impairment\n* Patients who anticipate receiving major surgery during the course of the\n* Pregnant or breastfeeding patients\n* Evidence of bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT00518557', 'acronym': 'TACE HCC', 'briefTitle': 'Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SIMCERE-123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'All patients of this arm are treated by TACE together with Andostatin.', 'interventionNames': ['Procedure: Transcatheter Arterial Chemoembolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.', 'interventionNames': ['Procedure: Transcatheter Arterial Chemoembolization']}], 'interventions': [{'name': 'Transcatheter Arterial Chemoembolization', 'type': 'PROCEDURE', 'otherNames': ['TAE'], 'description': 'The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-Hui Chen, MD', 'role': 'CONTACT', 'email': 'noriko0706@sohu.com', 'phone': '+86 25 83272121'}, {'name': 'Gang Deng, MD', 'role': 'CONTACT', 'email': 'dmm1996@sina.com', 'phone': '+86 25 83272118'}, {'name': 'Gang Deng, MD, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shi-Cheng He, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jin-He Guo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Interventional Radiology, Zhongda Hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xiao-Hui Chen, MD', 'role': 'CONTACT', 'email': 'noriko0706@sohu.com', 'phone': '+86 25 83272121'}, {'name': 'Gang Deng, MD, Ph.D', 'role': 'CONTACT', 'email': 'dmm1996@sina.com', 'phone': '+86 25 83272118'}], 'overallOfficials': [{'name': 'Gao-Jun Teng, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital, Southeast University, Nanjing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}}}}