Actively Recruiting
Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
Led by Peking Union Medical College Hospital · Updated on 2026-03-06
500
Participants Needed
1
Research Sites
573 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (218 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
B
binhe Tian
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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