Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01549093
Status:
UNKNOWN
Last Update Posted:
2015-03-24
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-01-26', 'releaseDate': '2016-12-03'}], 'estimatedResultsFirstSubmitDate': '2016-12-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C522911', 'term': 'endostar protein'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-22', 'studyFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'two years'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'two years'}, {'measure': 'The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.', 'timeFrame': 'two years'}, {'measure': 'adverse reaction', 'timeFrame': 'two years'}, {'measure': 'Time to progression(TTP)', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'Endostar', 'Continued Pumping into', 'Gemcitabine', 'Carboplatin'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.', 'detailedDescription': 'Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.\n\nMethods:\n\nIn this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically diagnosed NSCLC;\n2. primary treatment,inoperable stage III/IV NSCLC;\n3. Age of 18-70years; Gender Not Required;\n4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:\n\n liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\\^9/l, ANC≥2.0×10\\^9/l platelet count ≥100×10\\^9/l, Hb≥100 g/l;\n5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;\n6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);\n7. No history of serious drug allergy;\n8. Informed consent should be obtained before treatment.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;\n2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);\n3. Serious complications and investigator consider it is unsuited enrolling;\n4. Pregnant or lactating women;\n5. Allergic to research drug;\n6. participating in other experimental trials and receive the treatment in four weeks;\n7. The position that is for observing curative effect have a radiotherapy.'}, 'identificationModule': {'nctId': 'NCT01549093', 'briefTitle': 'Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'A Randomized, Open Label, Controlled Study About Endostar Continued Pumping or Injecting Into Vein Combining With Gemcitabine-Carboplatin Versus Gemcitabine-Carboplatin Alone to Treat Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'HunanPTH022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostar -Continued Pumping into+GC', 'description': 'Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin', 'interventionNames': ['Drug: Gemcitabine,Carboplatin,Endostar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endostar -injecting into +GC', 'description': 'Endostar that is injecting into vein with Gemcitabine -Carboplatin', 'interventionNames': ['Drug: Gemcitabine(G) Carboplatin(C) Endostar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GC', 'description': 'Gemcitabine -Carboplatin', 'interventionNames': ['Drug: Gemcitabine(G) Carboplatin(C)']}], 'interventions': [{'name': 'Gemcitabine,Carboplatin,Endostar', 'type': 'DRUG', 'description': 'Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2\\*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.', 'armGroupLabels': ['Endostar -Continued Pumping into+GC']}, {'name': 'Gemcitabine(G) Carboplatin(C) Endostar', 'type': 'DRUG', 'description': 'Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles', 'armGroupLabels': ['Endostar -injecting into +GC']}, {'name': 'Gemcitabine(G) Carboplatin(C)', 'type': 'DRUG', 'description': 'Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles', 'armGroupLabels': ['GC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Chen, master', 'role': 'CONTACT', 'email': 'cjh_1000@163.com', 'phone': '0086-731-89762221'}, {'name': 'Jianhua Chen, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HuNan province tumor hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Jianhua Chen, master', 'role': 'CONTACT', 'email': 'cjh_1000@163.com', 'phone': '0086-731-89762221'}], 'overallOfficials': [{'name': 'Jianhua Chen, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Province Tumor Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professer', 'investigatorFullName': 'Jianhua Chen', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-12-03', 'type': 'RELEASE'}, {'date': '2017-01-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jianhua Chen, professer, Hunan Province Tumor Hospital'}}}}