Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 6:00 AM
Study NCT ID:
NCT01327235
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2011-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522911', 'term': 'endostar protein'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'baseline to measured progressive disease, every three weeks', 'description': 'WHO criteria'}], 'secondaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'baseline to every three weeks until disease progression'}, {'measure': 'Quality of Life', 'timeFrame': 'baseline to every three weeks'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Up to 1 month after the last treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Pleural Effusion', 'Malignant Ascites']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of thoracic or abdominal tumor\n* At least medium amount of malignant pleural effusion or ascites\n* ECOG Performance Status 0-2\n* Life expectancy ≥ 2 months\n* Adequate hematologic, cardiac, renal, and hepatic function\n* No major surgery within 4 weeks prior to this study\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with central nervous system (CNS) metastases\n* Evidence of bleeding diathesis, serious infection\n* Evidence of myocardial infarction, unstable angina or cardiac insufficiency\n* Presence of serious COPD and/or respiratory failure\n* Allergic to study drug\n* Pregnant or lactating women\n* Participation in other clinical trials within 30 days prior to this study'}, 'identificationModule': {'nctId': 'NCT01327235', 'briefTitle': 'Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites', 'orgStudyIdInfo': {'id': 'SIM-90'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endostar', 'interventionNames': ['Drug: Endostar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cisplatin', 'interventionNames': ['Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Endostar and Cisplatin', 'interventionNames': ['Drug: Endostar', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Endostar', 'type': 'DRUG', 'description': 'intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles', 'armGroupLabels': ['Endostar', 'Endostar and Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles', 'armGroupLabels': ['Cisplatin', 'Endostar and Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'country': 'China', 'facility': 'The 81st Hospital of Chinese PLA', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Qingdao', 'country': 'China', 'facility': 'The Affiliated Hospital of Medical College, QingDao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shukui Qin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 81st Hospital of Chinese PLA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}