Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progress-free survival
研究概览
简要总结
The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.
详细描述
The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.
study design: open-labeled, active controlled, randomized, phase 2 treatments: experiment group will consist of intraperitoneal p53 (2 x 10^12 viral particles) plus cisplatin 150 mg/m^2, and Paclitaxel 175 mg/m^2 IV over 3 h on day 1; every 21 d for 6 cycles.
study end points: response rate, progression-free survival, overall survival and Karnofsky score（KPS).
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
- •histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer
- •18 years or older
- •with normal tests of hemogram, blood coagulation, liver and kidney function
- •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
p53 gene plus chemotherapy
Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
干预措施: p53 gene (Drug)
p53 gene plus chemotherapy
Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
干预措施: Cisplatin (Drug)
p53 gene plus chemotherapy
Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
干预措施: Paclitaxel (Drug)
chemotherapy
Intraperitoneal cisplatin, and paclitaxel iv
干预措施: Cisplatin (Drug)
chemotherapy
Intraperitoneal cisplatin, and paclitaxel iv
干预措施: Paclitaxel (Drug)
结局指标
主要结局
progress-free survival
时间窗: from starting treatment to 2 years after
measure the time to progression/death, or to the last tumor assessment
response rate
时间窗: from starting study treatment to 6 months
Objective response rate using RECIST version 1.1 guidance
次要结局
- Karnofsky Performance Status score（KPS）(from starting study treatment to 2 years after)
- safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination(from starting study treatment to 30 days after the last study treatment)
- overall survival(from starting study treatment to 2 years after)