Spots Global Cancer Trial Database for Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
Official Title: 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
Study ID: NCT03117335
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Bengbu medical college affiliated hospital, Bengbu, Anhui, China
The first affiliated hospital, anhui medical university, Hefei, Anhui, China
The second affiliated hospital, anhui medical university, Hefei, Anhui, China
Beijing Chest Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, 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, 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
Contact Details
Name: Yuankai Shi, M.D.
Affiliation: Cancer Hospital Chinese Academy of Medical Science
Role: PRINCIPAL_INVESTIGATOR
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