Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- occurrence of immune-related adverse event (irAE)
研究概览
简要总结
the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer
详细描述
After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18-80 years of age
- •Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques
- •Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)
排除标准
- •Other cancer treatment
- •Other malignancies
结局指标
主要结局
occurrence of immune-related adverse event (irAE)
时间窗: 12 months since immunotherapy initiation
Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented
次要结局
- Overall Survival(24 months since immunotherapy initiation)
- Progression Free Survival.(24 months since immunotherapy initiation)