Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT03117335
Last Updated: 2017-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
560 participants
INTERVENTIONAL
2011-11-10
2017-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vinorelbine plus Cisplatin With placebos
The control group
Placebos
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)
Vinorelbine plus Cisplatin With Sulijia
The treatment group
Sulijia
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)
Interventions
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Placebos
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)
Sulijia
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with histological confirmed stage IV NSCLC;
3. 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;
4. general condition ECOG performance scale (PS) 0-1;
5. Life expectancy of more than 3 months;
6. 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;
7. Patients could understand the circumstances of this study and those who have signed the informed consent form.
Exclusion Criteria
2. Patients who have uncontrolled brain metastasis;
3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;
4. Pregnant or lactating women;
5. Severe infected patients;
6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;
7. Patients who have vein thrombus;
8. Patients who have psychiatric illness;
9. Patients who are allergic to E. coli preparation;
10. Researchers believe that those who do not fit.
18 Years
70 Years
ALL
No
Sponsors
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Tigermed Consulting Co., Ltd
INDUSTRY
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuankai Shi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital Chinese Academy of Medical Science
Locations
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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 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
Countries
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Other Identifiers
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BA2010071
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TG1107RHE
Identifier Type: -
Identifier Source: org_study_id
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