A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Immunotherapy
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Autoantibodies
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Detailed Description
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.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years old.
- •Receiving anti-PD1 immunotherapy
Exclusion Criteria
- •Vital signs are unstable
- •Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.
Outcomes
Primary Outcomes
Autoantibodies
Time Frame: 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
Time Frame: baseline to Week 45
Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.
Secondary Outcomes
- the immune cell (Including T cell, B cell, etc.)(Week 45)
- the cytokine(Week 45)