Cancer immunotherapy side effects under the microscope: can patients safely resume treatment?
NCT ID NCT07453342
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This observational study tracks 500 cancer patients who have experienced immune-related side effects from immunotherapy drugs like checkpoint inhibitors. Researchers aim to understand how common these side effects are, how they are managed, and whether it is safe to restart immunotherapy after they resolve. The study also collects blood and tissue samples to explore why side effects happen.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Immune checkpoint inhibitors (drugs like anti-PD-1, anti-PD-L1, anti-CTLA-4)
- What this could lead to
- If successful, this study could help doctors better predict and manage immune-related side effects from cancer immunotherapy, and make safer decisions about restarting treatment.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not apply to all patients or cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult cancer patients treated with immune checkpoint inhibitors at Peking Union Medical College Hospital who develop immune-related adverse events during therapy. The study includes patients with various tumor types and organ-specific irAEs. Clinical data, management strategies, outcomes, and rechallenge status will be analyzed. Biospecimens may be collected when clinically indicated and available.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a single rituximab infusion tame Immunotherapy's harsh side effects?
- New drug cocktail aims to stop Chemo-Linked nausea before it starts