NCT02418481已完成1 期
γδ T Cell Immunotherapy for Treatment of Breast Cancer
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduced size of the tumors
研究概览
简要总结
In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
详细描述
Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-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
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Karnofsky performance status >50
- •Diagnosis with breast tumors based on histology or the current accepted radiological measures.
- •Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- •Will receive cryosurgery, gd Tcells/ DC-CIK.
- •Life expectancy: Greater than 3 months
- •Ability to understand the study protocol and a willingness to sign a written informed consent document
排除标准
- •Patients with other kinds of cancer
- •History of coagulation disorders or anemia
- •Patients with heart disease and diabetes
结局指标
主要结局
Reduced size of the tumors
时间窗: Up to one year
次要结局
未报告次要终点
研究者
研究点 (1)
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