A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Autoantibodies
研究概览
简要总结
The goal of this observational study is to learn about in the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:
- The autoantibody profile of patients
- The adverse reactions of patients
- The changes of immune cells and cytokine in patients
详细描述
The goal of this observational study is to learn about the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:
- The autoantibody profile of patients
- The adverse reactions of patients
- The changes of immune cells and cytokine in patients (e.g., T cell, B cell, IL-6, etc.)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Receiving anti-PD1 immunotherapy
排除标准
- •Vital signs are unstable
- •Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.
结局指标
主要结局
Autoantibodies
时间窗: Week 45
Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides). Cell transfection, ELISpot and ELISA are designed to be used.
the change of immune-related adverse events
时间窗: baseline to Week 45
Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.
次要结局
- the immune cell (Including T cell, B cell, etc.)(Week 45)
- the cytokine(Week 45)