NCT01128803终止1 期
Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative test for pregnancy or effective contraception
- •Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
- •HLA A 0201 group
排除标准
- •Life expectancy < 3 months
- •Pregnancy or breast-feeding
- •Severe auto-immune disease
- •Another malignant tumor except if considered as cured since more than 5 years
- •History of uncontrolled psychiatric condition
- •Risk factors of Creutzfeldt Jacobs disease
- •Decompensated cirrhosis(ascites or Child-Pugh score greater than 8)
- •Hepatic transplantation
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 3 months after the last injection
次要结局
- Analysis of T lymphocytes(3 months after the last injection)
研究者
研究点 (7)
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