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临床试验/NCT03183206
NCT03183206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 100 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
100
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 Breast Cancer 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, 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
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-75 Karnofsky performance status >50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 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 Insulin dependent diabetes Thyroid disease

结局指标

主要结局

Relief degree of tumors

时间窗: 3 months

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

研究者

发起方
Fuda Cancer Hospital, Guangzhou
申办方类型
Other
责任方
Sponsor

研究点 (1)

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