Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a Low-Dose steroid tame Immunotherapy's liver side effect?

NCT ID NCT07167251

Disease control Sponsor: University Hospital, Basel, Switzerland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether low-dose prednisolone (a steroid) can safely treat liver inflammation (hepatitis) caused by immune checkpoint inhibitors in cancer patients. Researchers will enroll 63 adults with grade 2 or 3 immune-related hepatitis and give them 0.5-1 mg/kg of prednisolone daily. The goal is to see if this low dose resolves the liver problem within 8 weeks without needing stronger drugs.

What this could mean

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

Active substance
Prednisolone (low-dose corticosteroid)
What this could lead to
If successful, this could show that low-dose steroids are enough to control immune-related hepatitis, reducing the need for stronger immunosuppressants.
What could go wrong
This is a small, early-stage registry study with only 63 participants, so results may not apply broadly. The treatment may not work for all patients or could require dose escalation.

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 63 people

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

Started

Aug 2025

Expected to finish

Dec 2026

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

The target patient population of this study are patients treated with immune checkpoint inhibitors (either as monotherapy with an anti-programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or as combination therapy with an PD-1 and CTLA-4 antibody, or an PD-1 and lymphocyte-activation gene 3 (LAG3) antibody) who develop grade 2 or 3 Immune-related hepatitis independently of the treated cancer entity.

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: 1. Cancer patients aged 18 years or older 2. Treatment with a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or a combination of a PD-1 and CTLA-4 antibody, or a PD-1 and lymphocyte-activation gene 3 (LAG-3) antibody 3. Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator) 4. Ability of the patient to comply with the study procedures (management of immune-related hepatitis) Exclusion Criteria: 1. Previous Immune-related hepatitis that required systemic therapy 2. Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (\>0.5 mg/kg body weight) 3. Immune-related hepatitis with bilirubin \> 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline) 4. Immune-related hepatitis with grade 4 at first presentation 5. Prior irAE treated with systemic immunosuppression 6. Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids) a. Patients with other immune-related adverse events may be included according to the investigator's judgment 7. Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson) a. Patients with liver metastasis are eligible 8. Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy). a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication. 9. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of \< 10mg prednisone equivalent are allowed.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune hepatitis cancer neoplasm

As listed by the trial registrant

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

Cancer Immune-mediated hepatitis Immune-related adverse events

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Royal Marsden Hospital

    NOT_YET_RECRUITING

    London, SW3 6JJ, United Kingdom

  • University Hospital Basel

    RECRUITING

    Basel, Canton of Basel-City, 4031, Switzerland

More trials for these conditions

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