NCT05023928已完成1 期
Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer
Sichuan University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
研究概览
简要总结
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
- •Immunotherapy for preoperative；
- •Karnofsky performance status 0-1;
- •The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
- •Function of the main organs is normal;
- •Edition Patient's written informed consent
排除标准
- •Tumor emergencies;
- •Abnormal coagulation function;
- •Contagious diseases, such as HIV, HBV, HCV infection;
- •Mental disorders;
- •Concomitant tumors;
- •Immunological co-morbidities
研究组 & 干预措施
Tumor antigen-sensitized DC vaccine
Experimental
Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times.
2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times.
干预措施: Tumor antigen-sensitized DC vaccine (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
时间窗: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
次要结局
- Disease-free Survival(through study completion, an average of 1 year)
研究者
Zhen-Yu Ding
Professor
Sichuan University
研究点 (1)
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