Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT02718859
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Irreversible Electroporation and NK Immunotherapy for Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-19', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree', 'timeFrame': '1 year', '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['advanced pancreatic cancer', 'nature killer cell', 'irreversible electroporation'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.', 'detailedDescription': 'By enrolling patients with pancreatic cancer 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 irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer.\n\nThe efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS).\n\nThe safety will be evaluated by statistics of adverse reaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:18-80\n2. Diagnosis：advanced and active pancreatic cancer\n3. The tumour is measurable\n4. Eastern Cooperative Oncology Group(ECOG) score：0\\~2；3 but has no relationship with tumour\n5. Vital organ function is normal:\n\n total bilirubin(TB) \\<68μmol/L aspartate aminotransferase(AST)\\<90 IU/L Cre\\<353μmol/L white blood cell count(WBC)\\<9×10\\^9/L,when WBC is close to or even greater than 9×10\\^9/L，the recommended dose should be halved platelet count(PLT)\\>80×10\\^9/L Red blood cell specific volume(HCT)\\>0.20 Non severe viral or bacterial infection\n6. Non pregnant and lactating patients\n7. Non allergic reactions to biological products\n8. Informed and consent\n\nExclusion Criteria:\n\n1. Patients with cardiac pacemaker\n2. Patients with severe cardiac and pulmonary dysfunction\n3. Patients that the researchers do not think fit into the group,including patients failed in compliance assessment'}, 'identificationModule': {'nctId': 'NCT02718859', 'briefTitle': 'Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'NK-pancre'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'irreversible electroporation (IRE)', 'description': 'Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy', 'interventionNames': ['Procedure: irreversible electroporation (IRE )']}, {'type': 'EXPERIMENTAL', 'label': 'IRE & NK cells', 'description': 'Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells', 'interventionNames': ['Biological: NK cells', 'Procedure: irreversible electroporation (IRE )']}], 'interventions': [{'name': 'NK cells', 'type': 'BIOLOGICAL', 'description': 'The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd', 'armGroupLabels': ['IRE & NK cells']}, {'name': 'irreversible electroporation (IRE )', 'type': 'PROCEDURE', 'description': 'The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )', 'armGroupLabels': ['IRE & NK cells', 'irreversible electroporation (IRE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Central laboratory in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Lizhi Niu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuda Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Hank Bioengineering Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}