Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 12:16 AM
Study NCT ID:
NCT03282435
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '5 years'}, {'measure': 'metastasis-free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-small cell lung cancer;\n* more than 50% tumor tissues positive with PD-L1;\n* EGFR and ALK wild type\n* no other tumors\n\nExclusion Criteria:\n\n* with systematic diseases shortening survival'}, 'identificationModule': {'nctId': 'NCT03282435', 'briefTitle': 'Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody', 'organization': {'class': 'OTHER', 'fullName': 'Dalian University'}, 'officialTitle': 'Treatment of Non-small Cell Lung Cancer With CIK Cells Blocked by PD-1 Antibody', 'orgStudyIdInfo': {'id': 'zsyy_zxsys2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIK cells with PD-1 blocking', 'description': 'CIK cellular therapy with PD-1 blocking combined with standard lung cancer treatment', 'interventionNames': ['Biological: CIK cells with PD-1 blocking', 'Other: standard lung cancer treament']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIK cells without PD-1 blocking', 'description': 'CIK cellular therapy without PD-1 blocking combined with the same standard lung cancer treatment as the experimental group patients receive', 'interventionNames': ['Other: standard lung cancer treament', 'Biological: CIK cells without PD-1 blocking']}], 'interventions': [{'name': 'CIK cells with PD-1 blocking', 'type': 'BIOLOGICAL', 'description': 'CIK cellular therapy with PD-1 blocking', 'armGroupLabels': ['CIK cells with PD-1 blocking']}, {'name': 'standard lung cancer treament', 'type': 'OTHER', 'description': 'standard non-small cell lung cancer treatment: surgery, chemotherapy', 'armGroupLabels': ['CIK cells with PD-1 blocking', 'CIK cells without PD-1 blocking']}, {'name': 'CIK cells without PD-1 blocking', 'type': 'BIOLOGICAL', 'description': 'CIK cellular therapy without PD-1 blocking', 'armGroupLabels': ['CIK cells without PD-1 blocking']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'haoren wang', 'role': 'CONTACT', 'email': 'haoren_wang@yahoo.com', 'phone': '86-041162893507'}], 'overallOfficials': [{'name': 'xiaolin Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Zhongshan Hospital of Dalian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'age, gender, tumor staging'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}