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.
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.
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.
Adult cancer patients treated with immune checkpoint inhibitors at Peking Union Medical College Hospital who develop immune-related adverse events during therapy. The study includes patients with various tumor types and organ-specific irAEs. Clinical data, management strategies, outcomes, and rechallenge status will be analyzed. Biospecimens may be collected when clinically indicated and available.
Cohort
Prospective
Immune Checkpoint Inhibitors
DrugImmune 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.
Incidence and Clinical Characteristics of Immune-Related Adverse Events During ICI Therapy
To evaluate the incidence, organ involvement, severity (CTCAE grading), timing of onset, and management patterns of immune-related adverse events occurring during immune checkpoint inhibitor therapy.
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