Cancer immunotherapy side effects under the microscope: can patients safely resume treatment?

NCT ID NCT07453342

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. 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

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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