Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
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.