Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
Peking Union Medical College Hospital
500 participants
Jan 1, 2023
OBSERVATIONAL
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.
Eligibility
Inclusion Criteria4
- Adults (≥18 years old) with a diagnosis of malignant tumor.
- Received treatment with immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 agents).
- Developed documented immune-related adverse events (irAEs) during ICI therapy, as determined by treating physicians.
- Availability of clinical data for evaluation of irAE characteristics and outcomes.
Exclusion Criteria3
- Patients receiving ICIs outside of the participating institution without accessible clinical records.
- Insufficient clinical information to determine irAE diagnosis or outcomes.
- Patients who decline use of their clinical data or biospecimens, when applicable.
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Interventions
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)
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NCT07453342