NCT01267578Unknown2 期
Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens (STF-II) for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
详细描述
The phase II multicenter trial of vaccination study using peptides derived from URLC10, CDCA1, and KOC1 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy are performed to evaluate the survival benefit of the cancer vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS
- •Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy
- •PATIENTS CHARACTERISTICS
- •ECOG performance status 0-2
- •Age≧20 years, 80≦years
- •WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
- •No therapy 4 weeks prior to the initiation of the trial
- •Able and willing to give valid written informed consent -
排除标准
- •Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Serious bleeding disorder
- •Serious infections requiring antibiotics
- •Concomitant treatment with steroids or immunosuppressing agent
- •Decision of unsuitableness by principal investigator or physician-in-charge -
结局指标
主要结局
overall survival
时间窗: death from start of treatment
次要结局
- Progression free survival(time from start of vaccination until disease progreesion)
- DTH response(Skin reaction after 5 round vaccination)
- CTL response(CTL response after 5 round vaccination)
研究者
研究点 (2)
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