Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-27 @ 3:27 AM
Study NCT ID:
NCT02843204
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2016-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 year', 'description': 'PFS was defined as the interval between treatment initiation and local relapse,'}, {'measure': 'OS', 'timeFrame': '3 years', 'description': 'OS was calculated as the interval from treatment initiation to death.'}], 'secondaryOutcomes': [{'measure': 'PD-1', 'timeFrame': '3 months', 'description': 'Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1'}, {'measure': 'Tumor size', 'timeFrame': '3 months', 'description': 'The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).'}, {'measure': 'CEA', 'timeFrame': '3 months', 'description': 'CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.'}, {'measure': 'CTC', 'timeFrame': '3 months', 'description': 'The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.'}]}, 'conditionsModule': {'keywords': ['Solid tumor', 'Anti-PD-1', 'NK immunotherapy'], 'conditions': ['Malignant Solid Tumour']}, 'referencesModule': {'references': [{'pmid': '32027620', 'type': 'DERIVED', 'citation': 'Lin M, Luo H, Liang S, Chen J, Liu A, Niu L, Jiang Y. Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients. J Clin Invest. 2020 May 1;130(5):2560-2569. doi: 10.1172/JCI132712.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.', 'detailedDescription': 'By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.\n\nThe safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence\n* Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement\n* KPS ≥ 70, lifespan \\> 3 months, PD-L1 TPS of 1% or greater\n* Platelet count ≥ 80×10\\^9/L，white blood cell count ≥ 3×10\\^9/L, neutrophil count ≥ 2×10\\^9/L, hemoglobin ≥ 80 g/L\n\nExclusion Criteria:\n\n* Patients with cardiac pacemaker\n* Patients with brain metastasis\n* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis\n* Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.'}, 'identificationModule': {'nctId': 'NCT02843204', 'briefTitle': 'Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors', 'orgStudyIdInfo': {'id': 'NK-PD-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab and NK immunotherapy', 'description': 'In this group, the patients will receive regular Pembrolizumab first to control tumor burden; then NK immunotherapy will be given. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Pembrolizumab', 'Biological: NK immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab', 'description': 'In this group, the patients will receive regular Pembrolizumab to control tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Keytruda'], 'description': 'Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure', 'armGroupLabels': ['Pembrolizumab', 'Pembrolizumab and NK immunotherapy']}, {'name': 'NK immunotherapy', 'type': 'BIOLOGICAL', 'description': 'Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.', 'armGroupLabels': ['Pembrolizumab and NK immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510665', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer Institute in Fuda Cancer Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jibing Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuda Cancer Hospital, Guangzhou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Hank Bioengineering Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}