Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed, previously untreated stage IIIB or IV NSCLC
- •age of 18-75 years
- •at least one measurable lesion (RECIST)
- •patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .
- •adequate hematologic, cardiac, renal, and hepatic function
- •ECOG PS 0-2
排除标准
- •symptomatic brain metastases
- •bone metastases with complications
- •major organ dysfunction
- •bleeding diathesis or coagulopathy
- •pregnant or lactating woman
研究组 & 干预措施
The control group
paclitaxel-carboplatin
干预措施: paclitaxel-carboplatin (Drug)
The treatment group
paclitaxel-carboplatin plus Endostar
干预措施: Endostar(Recombinant Human Endostatin Injection) (Drug)
The treatment group
paclitaxel-carboplatin plus Endostar
干预措施: paclitaxel-carboplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: every 2 months until disease progression
次要结局
- Objective Response Rate (ORR)(the end of each cycle)
- Overall Survival (OS)(2 years)