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Prednisone for Liver Protection During Radiation Therapy for Liver Cancer

This study is testing if a medication called prednisone can help protect the liver in people with hepatocellular carcinoma (a type of liver cancer) who are receiving stereotactic body radiation therapy (a focused type of radiation). You may be eligible if you have hepatocellular carcinoma, which is confirmed by biopsy or specific imaging criteria. Participants will take prednisone by mouth once a day for three days before starting radiation therapy and continue during the first three radiation treatments. The main goal is to see if prednisone can reduce liver inflammation, measured by sTNFR1 levels, at several time points up to six months after radiation therapy. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
What's involved
You would self-administer prednisone daily for three days before starting radiation therapy and continue during the first three radiation treatments. Your sTNFR1 levels will be measured at several time points.
Compensation
Not stated in the trial record.
Follow-up
Your sTNFR1 levels will be measured at 1, 3, and 6 months after starting radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05901519

A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~20 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Prednisone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mitigation of liver inflammation as reflected by sTNFR1 levels
Measured over at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy

Conditions

Hepatocellular Carcinoma

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NCT05901519

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rogel Comprehensive Cancer Center

    Ann Arbor, Michiganno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Theodore Lawrence · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Theodore Lawrence
[email protected]
7346479955
Email the study team

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Eligibility criteria

Inclusion

Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following:
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:
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

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.
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.

What this trial measures

  • Mitigation of liver inflammation as reflected by sTNFR1 levelsat 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%.