Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.
The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •historically diagnosed advanced non-small lung cancer
- •has surgery indication
- •age 18 years old or greater
- •life expectancy greater than 12 weeks
- •ECOG: 0-2
- •no prior chemotherapy, radiotherapy in 2 weeks
- •Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range
- •subject provides signed informed consent
排除标准
- •hypersensitive to study drug
- •with a coagulational test unnormal or a bleeding disorder
- •infections
- •with serious condition which can't stand a surgery
- •pregnant or lactating
- •principle investigator consider not suitable
研究组 & 干预措施
Surgery plus post-surgery chemotherapy
Surgery plus post-surgery chemotherapy
干预措施: Surgery (Procedure)
Surgery combined with rAd-p53 gene therapy
Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
干预措施: Surgery combined with rAd-p53 gene therapy (Drug)
结局指标
主要结局
overall survival
时间窗: 3 year after the treatment
determine the 3-years overall survival
adverse effects
时间窗: from starting treatment to 30 days after treatment
次要结局
- local recurrent rate(3 years)
- quality of life(3 years)