A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

Recruiting

• Conditions: ADR; Immunotherapy

• Registration Number: NCT05669638
• Lead Sponsor: Xuanwu Hospital, Beijing

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.)

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2023-01-03
• Study Start: 2023-05-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age ≥ 18 years old.
2. Receiving anti-PD1 immunotherapy

Exclusion Criteria

1. Vital signs are unstable
2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autoantibodies	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	baseline to Week 45	Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.

Secondary Outcome Measures

Name	Time	Method
the immune cell (Including T cell, B cell, etc.)	Week 45	Using flow cytometry
the cytokine	Week 45	Including IL-6, IL-17, etc.

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China