Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-29 @ 11:58 AM
Study NCT ID:
NCT02844335
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, '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': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-07-17', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree', '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 years'}]}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Cryosurgery', 'NK Immunotherapy'], 'conditions': ['Breast Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced breast cancer.', 'detailedDescription': 'By enrolling patients with breast 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 cryosurgery and nature killer (NK) cells for advanced breast cancer.\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': '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 \\< 5 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': 'NCT02844335', 'briefTitle': 'Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'orgStudyIdInfo': {'id': 'NK-breast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryosurgery and NK immunotherapy', 'description': 'In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).', 'interventionNames': ['Device: Cryosurgery', 'Biological: NK immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryosurgery', 'description': 'In this group, the patients will receive comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).', 'interventionNames': ['Device: Cryosurgery']}], 'interventions': [{'name': 'Cryosurgery', 'type': 'DEVICE', 'description': 'Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)', 'armGroupLabels': ['Cryosurgery', 'Cryosurgery and NK immunotherapy']}, {'name': 'NK immunotherapy', 'type': 'BIOLOGICAL', 'description': 'Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)', 'armGroupLabels': ['Cryosurgery 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': 'Guifeng Liu, 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'}}}}