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Can we predict dangerous side effects of cancer immunotherapy?

NCT ID NCT07357636

Knowledge-focused Sponsor: Shantou University Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 940 adult cancer patients starting immunotherapy to understand why some develop immune-related side effects, especially those affecting the brain and nerves. Researchers will collect blood samples and health data over time to find early warning signs. The goal is to better predict and manage these side effects, making immunotherapy safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to predict and manage immune-related side effects from cancer immunotherapy, improving patient safety and quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly benefit participants. It may not find clear biomarkers, and results may take years to impact clinical practice.

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 940 people

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

Started

Jan 2019

Expected to finish

Sep 2029

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 patients (≥18 years) with histologically confirmed solid malignancies who are initiating a new immune checkpoint inhibitor regimen, either as standard of care or within an approved clinical trial. Participants are enrolled prior to the first immune checkpoint inhibitor dose and followed longitudinally to assess the development of immune-related adverse events and associated immune and inflammatory biomarker changes.

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: * Age ≥18 years * Histologically confirmed solid malignancy * Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial * Ability to provide informed consent * Baseline study assessments and biospecimen collection completed prior to first ICI dose * Life expectancy of at least 6 months as determined by treating oncologist * Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable Exclusion Criteria: * Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation * Chronic systemic immunosuppression exceeding 10 mg/day prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses) * Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation * Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days) * Inability or unwillingness to provide required baseline biospecimens

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Conditions

The condition(s) this trial relates to.

neoplasm toxic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune-related adverse events Immunotherapy toxicity Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. 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.

    Open the record ↗

  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

  • Affiliated Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, China

  • First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 430074, China

  • Hainan Hospital of Chinese PLA General Hospital

    RECRUITING

    Sanya, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • the First Affiliated Hospital of Shantou University Medical College

    RECRUITING

    Shantou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.