Immune-related side effects from cancer immunotherapy and whether it's safe to restart treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort that collects detailed clinical information on immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy and documents subsequent clinical courses. Researchers will record timing, organ involvement, severity, management approaches, and outcomes of irAEs and will follow patients who are re-challenged with ICIs after resolution or stabilization. When clinically feasible, peripheral blood and organ-specific biospecimens will be collected to support exploratory immunologic and molecular analyses. The goal is to generate real-world evidence to improve risk stratification, toxicity management, and decision-making about continuing or restarting immunotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: binhe Tian
• Email: 17782646786@163.com
• Phone: 17782646786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.