NCT07453342 Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
| NCT ID | NCT07453342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Immune-Related Adverse Events |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2033-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-01-01 with a primary completion date of 2033-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07453342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune-Related Adverse Events. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07453342 currently recruiting?
Yes, NCT07453342 is actively recruiting participants. Contact the research team at 17782646786@163.com for enrollment information.
Where is the NCT07453342 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07453342 clinical trial?
NCT07453342 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 500 participants.