Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-04 @ 6:12 PM
Study NCT ID:
NCT02849366
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, '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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', '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': ['Sarcoma', 'Cryosurgery', 'NK Immunotherapy'], 'conditions': ['Recurrent Adult Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.', 'detailedDescription': 'By enrolling patients with recurrent sarcoma 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 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': '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': 'NCT02849366', 'briefTitle': 'Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'orgStudyIdInfo': {'id': 'NK-sarcoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryosurgery and NK immunotherapy', 'description': 'In this group, the patients will receive comprehensive cryosurgery to clear all big tumors and then receive multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and 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 clear all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Device: Cryosurgery']}], 'interventions': [{'name': 'Cryosurgery', 'type': 'DEVICE', 'otherNames': ['Argon-helium cryosurgical system'], 'description': 'Percutaneous ablation under CT or ultrasound guidance', 'armGroupLabels': ['Cryosurgery', 'Cryosurgery and NK immunotherapy']}, {'name': 'NK immunotherapy', 'type': 'BIOLOGICAL', 'description': 'Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.', 'armGroupLabels': ['Cryosurgery and NK immunotherapy']}]}, '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}}], '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'}}}}