NCT05317325Unknown1 期
A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma
Sichuan University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The number of treatment-related adverse events
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-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC
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
- •Pathologically confirmed diagnosis of esophageal squamous cell carcinoma
- •no preoperative adjuvant therapy
- •Karnofsky performance status 0-2;
- •The postoperative pathological stage is pT2-4 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
结局指标
主要结局
The number of treatment-related adverse events
时间窗: From the first administration of vaccine to 3 months after the last administration
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Disease-free Survival(from the study start to 1 year after the study completion)
研究者
Zhen-Yu Ding
Professor
Sichuan University
研究点 (1)
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