Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT03117335
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2017-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D043169', 'term': 'Endostatins'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': 'Assessed up to 24 months', 'description': 'A duration from date of randomization until the date of first documented progression (as defined by RECIST 1.1) or date of death from any cause, whichever came first. A participant will be censored at the last date they are known not to be progressed.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': 'Assessed up to 24 months', 'description': 'Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) (as defined by RECIST 1.1).'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': 'Assessed up to 24 months', 'description': 'Disease Control Rate is defined as the proportion of patients with complete response(CR), partial response(PR), or stable disease(SD) (as defined by RECIST 1.1).'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'Assessed up to 72 months', 'description': 'Overall Survival is assessed via calculation of the time to death due to any cause. A participant will be censored at the last date they are known to be alive.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small Cell Lung Cancer', 'Sulijia', 'Recombinant endostatin', 'Vinorelbine', 'Cisplatin'], 'conditions': ['Advanced Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia) combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) , disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.', 'detailedDescription': 'Recombinant endostatin injection Sulijia is a new type of recombinant protein drugs inhibiting tumor angiogenesis developed by a group of Chinese scientists and clinician. It is expressed in E. coli which Consists of 184 amino acids. It appears to be better than NP chemotherapy alone in terms of efficacy in phase I/II trials for advanced NSCLC. In this study, a randomized, double-blind, Placebo plus NP as control, multi-center phase III trial was designed to evaluate the safety and efficacy of Sulijia plus NP in the treatment of advanced NSCLC patients. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), DCR (disease control rate) and safety as the secondary end-point. A total of 560 patients have been recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female aged 18 to 70 years old;\n2. Patients with histological confirmed stage IV NSCLC;\n3. 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, PET-CT, with the largest diameter \\>=20mm by ordinary CT and MRI;\n4. general condition ECOG performance scale (PS) 0-1;\n5. Life expectancy of more than 3 months;\n6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \\> 1.5\\*10\\^9/L, platelet count\\> 90\\*10\\^9/L, hemoglobin\\> 9g/dL; liver function: serum bilirubin was less than 2\\* maximum normal value; ALT and AST were less than 2.5\\*maximum normal value; BUN, Cr within 80% of normal range;\n7. Patients could understand the circumstances of this study and those who have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time;\n2. Patients who have uncontrolled brain metastasis;\n3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;\n4. Pregnant or lactating women;\n5. Severe infected patients;\n6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;\n7. Patients who have vein thrombus;\n8. Patients who have psychiatric illness;\n9. Patients who are allergic to E. coli preparation;\n10. Researchers believe that those who do not fit.'}, 'identificationModule': {'nctId': 'NCT03117335', 'briefTitle': 'Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'Recombinant Endostatin With Vinorelbine and Cisplatin (NP) Plus Maintenance Therapy With Recombinant Endostatin for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study', 'orgStudyIdInfo': {'id': 'TG1107RHE'}, 'secondaryIdInfos': [{'id': 'BA2010071', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Department of Jiangsu Province'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vinorelbine plus Cisplatin With placebos', 'description': 'The control group', 'interventionNames': ['Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Vinorelbine plus Cisplatin With Sulijia', 'description': 'The treatment group', 'interventionNames': ['Drug: Sulijia']}], 'interventions': [{'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Sodium Chloride Injection'], 'description': 'Drug 1:\n\nPlacebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）\n\nDrug 2:\n\nVinorelbine-Cisplatin:\n\nVinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)', 'armGroupLabels': ['Vinorelbine plus Cisplatin With placebos']}, {'name': 'Sulijia', 'type': 'DRUG', 'otherNames': ['Recombinant endostatin injection'], 'description': 'Drug 1:\n\nSulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）\n\nDrug 2:\n\nVinorelbine-Cisplatin:\n\nVinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)', 'armGroupLabels': ['Vinorelbine plus Cisplatin With Sulijia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'Bengbu medical college affiliated hospital', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The first affiliated hospital, anhui medical university', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The second affiliated hospital, anhui medical university', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chest Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'First Affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical College', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Shantou Medical School', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guilin medical college affiliated hospital', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'The first affiliated hospital of xinxiang medical college', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'The Oncology Center of Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Changsha Central Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Yueyang', 'state': 'Hunan', 'country': 'China', 'facility': "Yueyang city people's hospital", 'geoPoint': {'lat': 29.37455, 'lon': 113.09481}}, {'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "The first People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "The People 's Liberation Army Eighth Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliate Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The first hospital affiliated to suzhou university', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': "The Fourth People's Hospital of Wuxi", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xuzhou medical college affiliated hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Siping', 'state': 'Jilin', 'country': 'China', 'facility': "People's hospital SiPingShi center", 'geoPoint': {'lat': 43.16143, 'lon': 124.37785}}, {'city': 'Yanji', 'state': 'Jilin', 'country': 'China', 'facility': 'Yanbian university hospital', 'geoPoint': {'lat': 42.88825, 'lon': 129.50241}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The tumor hospital of liaoning province', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'Ningxia medical university general hospital', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'city': 'Binzhou', 'state': 'Shandong', 'country': 'China', 'facility': 'Binzhou medical school affiliated hospital', 'geoPoint': {'lat': 37.36667, 'lon': 118.01667}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Central Hospital Affiliated of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital ,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Yibin', 'state': 'Sichuan', 'country': 'China', 'facility': "The second people's hospital of yibin city", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang cancer hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yuankai Shi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital Chinese Academy of Medical Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tigermed Consulting Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}