Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-03-09 @ 10:52 AM
Study NCT ID:
NCT02449967
Status:
WITHDRAWN
Last Update Posted:
2019-09-12
First Post:
2015-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for 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'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse events', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Percentage of lesions that show no sign of recurrence 12 months after interventional therapy', 'timeFrame': '1 year'}, {'measure': 'Progress free disease (PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'HepaSphere'], 'conditions': ['Pancreatic 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 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 HepaSphere interventional therapy using digital subtraction Angiography（DSA）for pancreatic 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 pancreatic 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 pancreatic cancer\n2. History of coagulation disorders or anemia"}, 'identificationModule': {'nctId': 'NCT02449967', 'briefTitle': 'HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Cancer: Clinical Trial', 'orgStudyIdInfo': {'id': 'Pancreatic Cancer HepaSphere'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HepaSphere', 'description': 'pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）', 'interventionNames': ['Procedure: interventional therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'pancreatic cancer patients did not receive any interventional therapy'}], 'interventions': [{'name': 'interventional therapy', 'type': 'PROCEDURE', 'description': 'pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）', 'armGroupLabels': ['HepaSphere']}]}, '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 Liu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuda Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}