NCT05901519 · University of Michigan Rogel Cancer Center
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
What this study is about
Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first three fractions of RT.
View original scientific description
Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first three fractions of RT.
Interventions
DRUG
Prednisone
Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day
Primary outcome measures
Mitigation of liver inflammation as reflected by sTNFR1 levels
Time frame: at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy
Measuring whether sTNFR1 level is attenuated following prednisone treatment, given before and during radiation therapy for HCC patients who are at high risk of radiation induced liver toxicity. sTNFR1 levels will be summarized descriptively at each time point as absolute values and change from baseline (prior to taking prednisone). Longitudinal regression models will be used to test whether mean changes over time are statistically significant. Treatment with prednisone will be considered successful if it causes a decrease in the level of sTNFR1 of 50%, which would be predicted to decrease toxicity by 15%.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following:
- Biopsy proven hepatocellular carcinoma (HCC); or
- 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:
- 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).
- Lesion(s) with a cumulative treatment diameter of ≥ 4cm.
- 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.
Where
- Ann Arbor, Michigan
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations