Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Advanced Non-small Cell Lung Cancer
- Interventions
- Drug: Placebos
- Registration Number
- NCT03117335
- Lead Sponsor
- Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
- Male and female aged 18 to 70 years old;
- Patients with histological confirmed stage IV NSCLC;
- 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;
- general condition ECOG performance scale (PS) 0-1;
- Life expectancy of more than 3 months;
- 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;
- Patients could understand the circumstances of this study and those who have signed the informed consent form.
- Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time;
- Patients who have uncontrolled brain metastasis;
- Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;
- Pregnant or lactating women;
- Severe infected patients;
- Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;
- Patients who have vein thrombus;
- Patients who have psychiatric illness;
- Patients who are allergic to E. coli preparation;
- Researchers believe that those who do not fit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vinorelbine plus Cisplatin With placebos Placebos The control group Vinorelbine plus Cisplatin With Sulijia Sulijia The treatment group
- Primary Outcome Measures
Name Time Method Progression Free Survival(PFS) Assessed up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Objective response rate(ORR) Assessed up to 24 months Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) (as defined by RECIST 1.1).
Disease control rate(DCR) Assessed up to 24 months 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).
Overall survival(OS) Assessed up to 72 months 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.
Trial Locations
- Locations (37)
Bengbu medical college affiliated hospital
🇨🇳Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
The first affiliated hospital, anhui medical university
🇨🇳Hefei, Anhui, China
The second affiliated hospital, anhui medical university
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Shantou Medical School
🇨🇳Shantou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Beijing Chest Hospital
🇨🇳Beijing, Beijing, China
Guilin medical college affiliated hospital
🇨🇳Guilin, Guangxi, China
The Oncology Center of Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhongnan hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The first hospital affiliated to suzhou university
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Affiliate Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The People 's Liberation Army Eighth Hospital
🇨🇳Nanjing, 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
Yanbian university hospital
🇨🇳Yanji, Jilin, China
The tumor hospital of liaoning province
🇨🇳Shenyang, Liaoning, 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
Ningxia medical university general hospital
🇨🇳Yinchuan, Ningxia, China
West China Hospital ,Sichuan University
🇨🇳Chengdu, Sichuan, China
Zhejiang cancer hospital
🇨🇳Hangzhou, Zhejiang, China
The second people's hospital of yibin city
🇨🇳Yibin, Sichuan, China
The first affiliated hospital of xinxiang medical college
🇨🇳Xinxiang, Henan, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
Yueyang city people's hospital
🇨🇳Yueyang, Hunan, China
The first People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
People's hospital SiPingShi center
🇨🇳Siping, Jilin, China