Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-22 @ 1:33 PM
Study NCT ID:
NCT02523404
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2015-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, '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': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2015-08-12', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse events', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Percentage of lesions interventional therapy that show no sign of recurrence 12 months after', 'timeFrame': '1 year'}, {'measure': 'Progress free disease (PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung Cancer', 'HepaSphere'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '23806858', 'type': 'BACKGROUND', 'citation': 'Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25937772', 'label': 'related information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.', 'detailedDescription': 'By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age:18-80\n2. Karnofsky performance status \\>60\n3. Diagnosis of lung cancer based on histology or the current accepted radiological measures.\n4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ\n5. Will receive interventional therapy\n6. Life expectancy: Greater than 3 months\n7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities\n8. Ability to understand the study protocol and a willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Patients with other primary tumor except lung cancer\n2. History of coagulation disorders or anemia"}, 'identificationModule': {'nctId': 'NCT02523404', 'briefTitle': 'HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Cancer: Clinical Trial', 'orgStudyIdInfo': {'id': 'Lung Cancer HepaSphere'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HepaSphere', 'description': 'lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）', 'interventionNames': ['Procedure: interventional therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'lung cancer patients received traditional therapy', 'interventionNames': ['Procedure: interventional therapy']}], 'interventions': [{'name': 'interventional therapy', 'type': 'PROCEDURE', 'description': 'lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）', 'armGroupLabels': ['HepaSphere', 'control']}]}, '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}