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Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
Sponsor: Peking Union Medical College Hospital
Summary
This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of ICI rechallenge following irAE resolution. In addition to detailed clinical data collection, the study incorporates biospecimen acquisition, when clinically indicated and feasible, including peripheral blood and organ-specific specimens (e.g., bronchoalveolar lavage fluid for ICI-related pneumonitis, liver biopsy tissue for ICI-related hepatitis, and other relevant clinical specimens). These samples will support exploratory immunologic and molecular analyses to better understand mechanisms underlying irAE development, resolution, and recurrence after rechallenge. This study is designed to generate real-world evidence to improve risk stratification, toxicity management, and decision-making regarding immunotherapy continuation or re-initiation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-01-01
Completion Date
2033-12-31
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Immune Checkpoint Inhibitors
Immune checkpoint inhibitors (ICIs), including anti-PD-1, anti-PD-L1, and anti-CTLA-4 monoclonal antibodies, administered according to standard clinical practice for the treatment of malignancies. Treatment regimens, dosing schedules, and duration are determined by treating physicians based on approved indications and institutional protocols.
Locations (1)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China