NCT02704299Unknown早期 1 期
A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Shanghai AbelZeta Ltd.0 个研究点目标入组 36 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 36
- 主要终点
- Progression-Free-Survival(PFS)
研究概览
简要总结
Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.
详细描述
Safety:AE/SAE Efficacy:immunologic function;FPS
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
- •Aged between 18 to 80 years, males and females.
- •Subjects who understand and sign the consent form for this study.
- •The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes.
- •Subjects are surgical candidates.
- •No distant metastasis (M0) and No distant lymph node metastasis.
- •Expected survival time of at least 6 months.
排除标准
- •Subjects who do not sign the consent form for this study.
- •The subject has an allergic history of medicine or food.
- •The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system.
- •The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
- •The subject has an history of other malignant tumour.
- •The subject has history of alcoholism, drug abuse, or mental illness in the 12 years prior to this trial.
- •The subject has participated in any other clinical trial in the 3 months prior to this trial.
- •The subject is pregnant, lactating or planning to conceive within the next 24 months.
- •The subject has any other unsuitable or adverse condition to be determined by the investigator.
结局指标
主要结局
Progression-Free-Survival(PFS)
时间窗: 24months
The primary objective is to assess progression free survival (PFS).
次要结局
- Incidences of adverse events or serious adverse events(24months)
研究者
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