Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.
详细描述
To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.
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 head and neck cancer;
- •unresectable, locally advanced;
- •18 years or older;
- •with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- •with normal tests of hemogram, blood coagulation, liver and kidney function; 6.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
rAd-p53 plus radiation and chemotherapy
rAd-p53 tumor injection combined with radio- and chemo-therapy.
干预措施: rAd-p53 (Drug)
rAd-p53 plus radiation and chemotherapy
rAd-p53 tumor injection combined with radio- and chemo-therapy.
干预措施: radiation (Radiation)
rAd-p53 plus radiation and chemotherapy
rAd-p53 tumor injection combined with radio- and chemo-therapy.
干预措施: Cisplatin (Drug)
radiation and chemotherapy
radiation combined with chemotherapy
干预措施: radiation (Radiation)
radiation and chemotherapy
radiation combined with chemotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
progression-free survival
时间窗: three years after starting treatment
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.
次要结局
- Adverse events(from starting study treatment until 30 days after the last study treatment)
- overall survival(three years after starting study treatment)