Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-01 @ 6:18 PM
Study NCT ID:
NCT03183232
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2017-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficiency of γδ T Cell Against Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree of tumors', 'timeFrame': '3 months', 'description': 'It will be evaluated by the Response Evaluation Criteria in Solid Tumors'}, {'measure': 'Progress free survival（PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival（OS）', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy, γδ T Cell, Lung Cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated', 'detailedDescription': 'Lung 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.\n\nNOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \\~ 3 weeks.\n\nTherefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 18-75 Karnofsky performance status \\>50 Diagnosis with Lung Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document\n\nExclusion Criteria:\n\nPatients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease'}, 'identificationModule': {'nctId': 'NCT03183232', 'briefTitle': 'Safety and Efficiency of γδ T Cell Against Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'γδ T Cell Immunotherapy for Treatment of Lung Cancer', 'orgStudyIdInfo': {'id': 'Gd T cell and lung Ca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor', 'interventionNames': ['Procedure: Cryosurgery or IRE surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell)', 'interventionNames': ['Biological: γδ T cell']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery', 'interventionNames': ['Other: γδ T cells/ A Cryosurgery or IRE']}], 'interventions': [{'name': 'Cryosurgery or IRE surgery', 'type': 'PROCEDURE', 'description': 'Cryosurgery or IRE surgery will be used in local tumor', 'armGroupLabels': ['Group A']}, {'name': 'γδ T cell', 'type': 'BIOLOGICAL', 'description': 'γδ T cells will be used against Lung Cancer', 'armGroupLabels': ['Group B']}, {'name': 'γδ T cells/ A Cryosurgery or IRE', 'type': 'OTHER', 'description': 'Combination γδ T cell and Cryosurgery or IRE surgery will be used in Lung Cancer', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510665', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Biotherapy center in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jibing Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinan University Guangzhou', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}