Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.
详细描述
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.
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
- Double (Participant, Investigator)
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
- •histopathologically diagnosed original cancer with malignant pleural effusion;
- •18 years or older;
- •with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
- •signed the informed consent form
排除标准
- •Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- •have serious heart, lung function abnormalities or severe diabetes patients;
- •active infection;
- •severe atherosclerosis;
- •AIDS patients;
- •serious thrombotic or embolic events within 6 months;
- •renal insufficiency requiring hemodialysis or peritoneal dialysis;
- •pregnant or lactating women;
- •mental disorder or disease.
研究组 & 干预措施
rAdp53
2 x 10^12 viral particles of rAdp53 gene are given in 40 ml of saline by intra-cavity infusion at day of 7, 15 and 21
干预措施: rAdp53 (Drug)
cisplatin
cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
干预措施: Cisplatin (Drug)
rAdp53 plus cisplatin
2 x 10^12 viral particles of rAdp53 gene and cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
干预措施: rAdp53 plus cisplatin (Drug)
结局指标
主要结局
objective response rate
时间窗: from starting study treatment to 3 months
the rate of complete response and partial response
次要结局
- effusion-free survival(from starting study treatment to 2 years)
- adverse events(from starting study treatment to 30 days after the last treatment)
- Karnofsky Performance Status(from starting study treatment to 2 years)