Steroid shield: prednisone may protect liver during cancer radiation
NCT ID NCT05901519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking prednisone, a steroid, before and during radiation therapy can protect the liver in people with liver cancer. About 20 participants will take prednisone for a short time around their radiation sessions. The goal is to see if it reduces liver inflammation and lowers the risk of liver damage from radiation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Aug 2026
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.
- 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: * Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following: 1. Biopsy proven hepatocellular carcinoma (HCC); or 2. A discrete hepatic tumor(s) as defined by the AASLD criteria (80) - for cirrhotic patients, \>1cm with arterial hypervascularity and venous or delayed phase washout on contrast enhanced CT or MRI. * Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, or TACE), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy. * Patients must have a performance status of ≤2. * Patients must be 18 years of age or older. * Patients with at least one of the following: 1. ALBI score equal to (-1.81) or higher (worse). This value was calculated as the equivalent ALBI score for CP score equal 7 in Cousins et al study's cohort(59). 2. Lesion(s) with a cumulative treatment diameter of ≥ 4cm. 3. CP score equal to 7 or higher (worse). * Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Exclusion Criteria: * Any serious disease, comorbidity or intercurrent illness which precludes delivery of radiation therapy, as determined by the treating investigator. * Any contraindication to the administration of steroids, including * Documented hypersensitivity to prednisone or any component of the formulation. * Systemic fungal infection. * Patients with uncontrolled infections or with chronic infections requiring antibiotics. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. * Uncontrolled hyperglycemia. * Patients with insulin -dependent diabetes. * Patients with decompensated liver disease, defined as: clinical ascites requiring paracentesis, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage. * Active gastrointestinal bleeding within 30 days of enrollment.
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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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Rogel Comprehensive Cancer Center
RECRUITINGAnn Arbor, Michigan, 48187, United States
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