NCT03180437已完成1 期
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年6月15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
- 62
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.
详细描述
Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.
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
- 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
- •age: >18 years
- •participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
- •will receive IRE, gd Tcells
- •life expectancy: more than 3 months
- •ability to understand the study protocol and a willingness to sign a written informed consent document
- •adequate liver and renal function were required
- •intolerant or refused to chemotherapy or to chemotherapy
排除标准
- •patients with other kinds of cancer
- •history of coagulation disorders or anemia
- •heart disease and diabetes
- •history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease
- •a performance status score of >2
结局指标
主要结局
PFS
时间窗: 2 years
PFS was defined as the interval between treatment initiation and local relapse
OS
时间窗: 2 year
OS was calculated as the interval from treatment initiation to death.
次要结局
- Tumor size(3 months)
- CTC(3 months)
- CA 19-9(3 months)
研究者
研究点 (1)
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