Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-31 @ 10:20 PM
Study NCT ID:
NCT02425735
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-17', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced size of the tumors', 'timeFrame': 'Up to one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunotherapy, γδ T Cell, heptocellular liver cancer'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '30736852', 'type': 'DERIVED', 'citation': 'Alnaggar M, Xu Y, Li J, He J, Chen J, Li M, Wu Q, Lin L, Liang Y, Wang X, Li J, Hu Y, Chen Y, Xu K, Wu Y, Yin Z. Allogenic Vgamma9Vdelta2 T cell as new potential immunotherapy drug for solid tumor: a case study for cholangiocarcinoma. J Immunother Cancer. 2019 Feb 8;7(1):36. doi: 10.1186/s40425-019-0501-8.'}]}, 'descriptionModule': {'briefSummary': 'In this study, effects of γδT cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.', 'detailedDescription': 'Liver tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:18-75\n2. Karnofsky performance status \\>50\n3. Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.\n4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ\n5. Will receive cryosurgery, gd Tcells/ DC-CIK.\n6. Life expectancy: Greater than 3 months\n7. Ability to understand the study protocol and a willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Patients with other kinds of cancer\n2. History of coagulation disorders or anemia\n3. Patients with heart disease and diabetes'}, 'identificationModule': {'nctId': 'NCT02425735', 'briefTitle': 'Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer', 'orgStudyIdInfo': {'id': 'Gd T cell and Hepatocellular'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'DC-CIK cells will be used against tumor cells.', 'interventionNames': ['Biological: DC-CIK cells']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'γδ T cells will be used against tumor cells.', 'interventionNames': ['Biological: γδ T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Combination of γδ T cells/ DC-CIK be used against tumor cells.', 'interventionNames': ['Biological: γδ T/DC-CIK cells']}], 'interventions': [{'name': 'DC-CIK cells', 'type': 'BIOLOGICAL', 'description': 'DC-CIK cells will be used against tumor cells.', 'armGroupLabels': ['Group A']}, {'name': 'γδ T cells', 'type': 'BIOLOGICAL', 'description': 'γδ T cells will be used against breast tumor.', 'armGroupLabels': ['Group B']}, {'name': 'γδ T/DC-CIK cells', 'type': 'BIOLOGICAL', 'description': 'γδ T/DC-CIK cells will be used against breast tumor.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Biological treatment center in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinan University Guangzhou', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}