Immune-related side effects from cancer immunotherapy and whether it's safe to restart treatment
Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
Peking Union Medical College Hospital · NCT07453342
This project will see if restarting immune checkpoint drugs after immune-related side effects is safe for adults with cancer who had those side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07453342 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with a malignant tumor who received anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy and developed documented immune-related adverse events with available clinical data are ideal candidates.
Not a fit: Patients without documented irAEs, those treated outside participating institutions without accessible records, or those who decline use of their data or biospecimens are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors decide when it is safer to restart immunotherapy and reduce unnecessary treatment stops while better managing risks.
How similar studies have performed: Prior retrospective and observational series have shown mixed results—some patients tolerate ICI rechallenge but recurrence rates and severity vary—so the approach has partial support but is not definitively settled.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immune-Related Adverse Events