Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-06 @ 10:48 AM
Study NCT ID:
NCT03008304
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', '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（RECIST）'}], 'secondaryOutcomes': [{'measure': 'Progress free survival（PFS）', 'timeFrame': '1 year'}, {'measure': 'Overall survival（OS）', 'timeFrame': '3 year'}]}, 'conditionsModule': {'keywords': ['Metastatic pancreatic cancer', 'High-activity natural killer Immunotherapy'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.', 'detailedDescription': 'By enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer 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'], 'maximumAge': '60 Years', 'minimumAge': '30 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* Body tumor 1-6, the maximum tumor length \\< 2 cm\n* KPS ≥ 70, lifespan \\> 6 months\n* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/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'}, 'identificationModule': {'nctId': 'NCT03008304', 'briefTitle': 'High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'orgStudyIdInfo': {'id': 'HANK-pancreas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-activity natural killer', 'description': 'In this group, the patients will receive multiple high-activity natural killer immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: High-activity natural killer']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In this group, the patients will receive no special treatment. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).'}], 'interventions': [{'name': 'High-activity natural killer', 'type': 'DRUG', 'otherNames': ['HANK cell'], 'description': 'Each treatment: 8\\~10 billion cells in all, transfuion in 3 times, i.v.', 'armGroupLabels': ['High-activity natural killer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510665', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Fuda cancer institute of Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Hank Bioengineering Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}