Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Who Survived at 1 Year
研究概览
简要总结
The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer
详细描述
The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.
Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.
The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
- •HLA-A2 expression by tumor cells;
- •WT-1/MUC-1 expression by tumor cells.
排除标准
- •refuse of patient to participate in the trial;
- •pregnancy/lactation;
- •intercurrent severe chronic diseases;
- •HIV, Hepatites B/C;
- •active tuberculosis;
- •alcohol use disorder/drug addiction.
结局指标
主要结局
Number of Participants Who Survived at 1 Year
时间窗: 1 year
1 year overall survival
Number of Participants with PR or CR at 1 year
时间窗: 1 year
1 year PR/CR
次要结局
- Number of Participants Who Survived at 3 Years or more(3 years)
- Immune response(1 year)
- Antigen-specific immune response(1 year)
- Circulating tumor cells count(1 year)
- Number of Participants Who Survived at 2 Years(2 years)
研究者
Andrei Y. Hancharou
Head of the Laboratory for Immunology and Cellular Biotechnology
The Republican Research and Practical Center for Epidemiology and Microbiology