Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Recurrence rate after surgery (TUR-BT)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt
详细描述
DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the prevention of the recurrence of the bladder cancer after surgery using these peptides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- •Serious infections requiring antibiotics
- •Concomitant treatment with steroids or immunosuppressing agent
- •Other malignancy difficult to control.
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
Recurrence rate after surgery (TUR-BT)
时间窗: 2 years
次要结局
- feasibility(2 years)
- CTL response(2 years)
- CD8 population(2 years)
- Change in level of regulatory T cells(2 years)
- Overall survival(5 years)