Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 5:19 PM
Study NCT ID:
NCT02509169
Status:
UNKNOWN
Last Update Posted:
2015-07-27
First Post:
2015-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016158', 'term': 'Genes, p53'}], 'ancestors': [{'id': 'D016147', 'term': 'Genes, Tumor Suppressor'}, {'id': 'D052138', 'term': 'Genes, Neoplasm'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005808', 'term': 'Genes, Recessive'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2015-07-19', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years', 'description': 'overall survival will be follow up to 2 years'}], 'secondaryOutcomes': [{'measure': 'immuno-reaction (lymphocyte counts and subgroup ratios)', 'timeFrame': '3 months', 'description': 'The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment'}, {'measure': 'progression free survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Hepatocellular Carcinoma (HCC)']}, 'descriptionModule': {'briefSummary': 'An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).', 'detailedDescription': "Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histopathologically diagnosed unresectable HCC\n* over 18 years old\n* with an Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C\n* with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function\n* signed the informed consent form.\n\nExclusion Criteria:\n\n* hypersensitive to study drug\n* With an abnormal coagulation condition or bleeding disorder\n* infections\n* with serious conditions which prevent using the study treatment\n* pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02509169', 'briefTitle': 'Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen SiBiono GeneTech Co.,Ltd'}, 'officialTitle': 'Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study', 'orgStudyIdInfo': {'id': 'TCAp53-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAE plus p53 gene', 'description': 'Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month', 'interventionNames': ['Drug: TAE plus P53 gene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAE', 'description': 'Trans-catheter embolization (TAE) will be given once per month', 'interventionNames': ['Other: TAE']}], 'interventions': [{'name': 'TAE plus P53 gene', 'type': 'DRUG', 'description': 'Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy', 'armGroupLabels': ['TAE plus p53 gene']}, {'name': 'TAE', 'type': 'OTHER', 'description': 'Trans-catheter embolization', 'armGroupLabels': ['TAE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuewei Zhang, MD, Ph D', 'role': 'CONTACT', 'email': 'zhangyuewei1121@sina.com'}], 'facility': 'first affiliated hospital in Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'centralContacts': [{'name': 'Yuewei Zhang, MD and Ph D', 'role': 'CONTACT', 'email': 'zhangyuewei1121@sina.com'}, {'name': 'Gui Gao, MD, Ph D', 'role': 'CONTACT', 'email': 'scottgao1110@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen SiBiono GeneTech Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}