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| ID | Type | Description | Link |
|---|---|---|---|
| BA2010071 | Other Grant/Funding Number | Science and Technology Department of Jiangsu Province |
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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vinorelbine plus Cisplatin With placebos | Active Comparator | The control group |
|
| Vinorelbine plus Cisplatin With Sulijia | Experimental | The treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | Drug 1: Placebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle(stop interventing until the disease progress) Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | 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. | Assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) (as defined by RECIST 1.1). | Assessed up to 24 months |
| Disease control rate(DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, M.D. | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bengbu medical college affiliated hospital | Bengbu | Anhui | China | |||
| The first affiliated hospital, anhui medical university |
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Parallel Assignment
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Double-Blind
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|
| Sulijia | Drug | Drug 1: Sulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle(stop interventing until the disease progress) Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 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) |
|
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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).
| Assessed up to 24 months |
| Overall survival(OS) | 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. | Assessed up to 72 months |
| Hefei |
| Anhui |
| China |
| The second affiliated hospital, anhui medical university | Hefei | Anhui | China |
| Beijing Chest Hospital | Beijing | Beijing Municipality | China |
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| The First Affiliated Hospital of Guangzhou Medical College | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Shantou Medical School | Shantou | Guangdong | China |
| Guilin medical college affiliated hospital | Guilin | Guangxi | China |
| The first affiliated hospital of xinxiang medical college | Xinxiang | Henan | China |
| The Oncology Center of Wuhan Union Hospital | Wuhan | Hubei | China |
| Zhongnan hospital of Wuhan University | Wuhan | Hubei | China |
| Changsha Central Hospital | Changsha | Hunan | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Yueyang city people's hospital | Yueyang | Hunan | China |
| The first People's Hospital of Changzhou | Changzhou | Jiangsu | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | China |
| The People 's Liberation Army Eighth Hospital | Nanjing | Jiangsu | China |
| Affiliate Hospital of Nantong University | Nantong | Jiangsu | China |
| The first hospital affiliated to suzhou university | Suzhou | Jiangsu | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| The Fourth People's Hospital of Wuxi | Wuxi | Jiangsu | China |
| Xuzhou medical college affiliated hospital | Xuzhou | Jiangsu | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| People's hospital SiPingShi center | Siping | Jilin | China |
| Yanbian university hospital | Yanji | Jilin | China |
| The tumor hospital of liaoning province | Shenyang | Liaoning | China |
| Ningxia medical university general hospital | Yinchuan | Ningxia | China |
| Binzhou medical school affiliated hospital | Binzhou | Shandong | China |
| Jinan Central Hospital Affiliated of Shandong University | Jinan | Shandong | China |
| Linyi Cancer Hospital | Linyi | Shandong | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
| West China Hospital ,Sichuan University | Chengdu | Sichuan | China |
| The second people's hospital of yibin city | Yibin | Sichuan | China |
| Zhejiang cancer hospital | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
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