The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Woman in pregnancy and breast-feeding, or having productive ability without contraception;
- •Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;
- •Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;
- •Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;
- •Having the tendency of bleeding, such as FIB≤2G/L;
- •Being receiving adjuvant chemotherapy;
- •On other conditions investigator considers, the subject is not fitful to participate the trial.
研究组 & 干预措施
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
干预措施: Endostar (Drug)
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
干预措施: Docetaxel (Drug)
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
干预措施: Carboplatin (Drug)
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
干预措施: Pemetrexed (Drug)
结局指标
主要结局
ORR
时间窗: 8 weeks
objective response rate based on Recist 1.1 edition
次要结局
- PFS(8 weeks)