Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.
详细描述
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed non-small cell lung cancer
- •failed in previous standard chemotherapy and targeted therapy
- •anticipated life time > 3month
- •Karnofsky performance status 0-1
- •rehabilitate from previous therapy
- •adequate organ functions
排除标准
- •mixed histological types
- •tumor emergency
- •abnormal coagulation condition
- •contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- •concomitant tumors
- •immunological co-morbidities
研究组 & 干预措施
cell_therapy
tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times
干预措施: DC vaccine (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- objective response rate(through study completion, an average of 1 year)
研究者
Zhen-Yu Ding
Professor
Sichuan University