Hepatocellular CarcinomaPhase 2NCT05901519
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
A Phase 2 study testing Prednisone in people with Hepatocellular Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rogel Comprehensive Cancer Center
Ann Arbor, Michigan, 48187
Theodore Lawrence, M.D., Ph.D.
Theodore Lawrence, M.D., Ph.D.
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Prednisone
- Keywords
- Radiation Therapy, Prednisone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Prednisone | Experimental | Prednisone will be administered for three days before starting RT, and during the first three fractions of RT. Following an interim analysis of the decrease in sTNFR1 level, a decision will be made whether to administer prednisone for seven days prior to RT, and to continue for additional seven days during RT. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitigation of liver inflammation as reflected by sTNFR1 levels
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%.
Measured: at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy
Secondary outcomes (5)
Estimating the safety of the steroid treatment
Define steroid administration protocol based on the rate of drug-related grade 3-5 adverse events attributable to the study drug and experienced within the first 6 weeks of study treatment. These will be assessed via NCI's CTCAE version 5.0. Toxicity rates for patients on this study will be compared to a propensity matched historical control cohort of recently treated patients at UM who were not treated with prednisone.
Measured: up to 6 weeks from start of study treatment
Percent of patients who complete of the proposed steroid treatment
Successful completion of steroid treatment.
Measured: up to 6 weeks from start of study treatment
Evaluate whether steroid treatment reduces radiation-induced liver toxicity
Rate of liver decompensation (as measured by worsening in ALBI score>0.5) or grade 3-5 GI bleeding during the subsequent 6 months following radiation treatment. The former are laboratory values that are already collected as part of standard of care. The latter will be assessed via the NCI CTCAE version 5.
Measured: up to 6 weeks from start of study treatment
Assess whether steroids have a durable ability to attenuate the level of inflammation as reflected by sTNFR1 level
Determining the mitigation of the inflammatory state, as reflected by biomarkers previously proposed in the literature to correlate with radiation-induced liver injury.
Measured: up to 6 months from start of study treatment
Assess tumor response
assessing tumor response as part of standard of care to determine response rate
Measured: up to 6 months from start of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start16 Feb 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore Lawrence, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901519
- Sponsor's protocol ID
- UMCC 2022.120
- Other IDs
- HUM00234029
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05901519
- Acronym / sponsor ID
- UMCC 2022.120
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Radiation Therapy, Prednisone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Prednisone | Experimental | Drug: PrednisonePrednisone will be administered for three days before starting RT, and during the first three fractions of RT. Following an interim analysis of the decrease in sTNFR1 level, a decision will be made whether to administer prednisone for seven days prior to RT, and to continue for additional seven days during RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisonePatients will be treated with PO prednisone, once a day, at a dose of 60 mg/day | Drug | Patients treated with Prednisone |
Primary outcome
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%.
5 secondary outcomes
Estimating the safety of the steroid treatment
Time frame: up to 6 weeks from start of study treatment
Percent of patients who complete of the proposed steroid treatment
Time frame: up to 6 weeks from start of study treatment
Evaluate whether steroid treatment reduces radiation-induced liver toxicity
Time frame: up to 6 weeks from start of study treatment
Assess whether steroids have a durable ability to attenuate the level of inflammation as reflected by sTNFR1 level
Time frame: up to 6 months from start of study treatment
Assess tumor response
Time frame: up to 6 months from start of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodore Lawrence principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone in people with Hepatocellular Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theodore Lawrence (7346479955, tsl@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.