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

NCT05901519 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: UMCC 2022.120HUM00234029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Radiation Therapy; Prednisone

Outcome Measures

Primary Outcomes (1)

• 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%.

  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

  up to 6 weeks from start of study treatment

• Percent of patients who complete of the proposed steroid treatment

  up to 6 weeks from start of study treatment

• Evaluate whether steroid treatment reduces radiation-induced liver toxicity

  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

  up to 6 months from start of study treatment

• Assess tumor response

  up to 6 months from start of study treatment

Study Arms (1)

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.

Drug: Prednisone

Interventions

Prednisone DRUG

Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day

Patients treated with Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

Rogel Comprehensive Cancer Center

Ann Arbor, Michigan, 48187, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Theodore Lawrence

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodore Lawrence

CONTACT

7346479955; tsl@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 13, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)