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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 37
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vinorelbine plus Cisplatin With placebos
The control group
干预措施: Placebos (Drug)
Vinorelbine plus Cisplatin With Sulijia
The treatment group
干预措施: Sulijia (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: 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.
次要结局
- Objective response rate(ORR)(Assessed up to 24 months)
- Disease control rate(DCR)(Assessed up to 24 months)
- Overall survival(OS)(Assessed up to 72 months)