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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Incidence and Clinical Characteristics of Immune-Related Adverse Events During ICI Therapy — From initiation of ICI therapy through last follow-up (up to 24 months)
  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.

Trial sites (1)

More Peking Union Medical College Hospital trials in China

Other trials for the same condition