γδ T Cell Immunotherapy for Treatment of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief degree of tumors
研究概览
简要总结
In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated
详细描述
Lung 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 an immunotherapy treatment.
NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.
Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 Karnofsky performance status >50 Diagnosis with Lung Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells 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
结局指标
主要结局
Relief degree of tumors
时间窗: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors
Progress free survival（PFS)
时间窗: 1 year
Overall survival（OS）
时间窗: 3 years
次要结局
未报告次要终点