NCT02585908Unknown1 期
γδ T Cell Immunotherapy for Treatment of Gastric Cancer
Beijing Doing Biomedical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年12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
- 120
- 试验地点
- 4
- 主要终点
- Reduced size of the tumor.
研究概览
简要总结
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.
详细描述
PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance status >50
- •Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
- •Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- •Patients who have a life expectancy of at least 12 weeks
- •Ability to understand the study protocol and a willingness to sign a written informed consent document
排除标准
- •Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- •Known human immunodeficiency virus (HIV) infection.
- •Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- •Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
结局指标
主要结局
Reduced size of the tumor.
时间窗: up to one year
Tumor load will be evaluated by RECIST criteria.
次要结局
- Safety, as measured by the rate of adverse events and serious adverse events(up to two years)
研究者
研究点 (4)
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