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

Inclusion Criteria:

• Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellularcarcinoma 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) - forcirrhotic patients, >1cm with arterial hypervascularity and venous or delayedphase 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 lastprocedure 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 theequivalent 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 approvedfor this purpose by the Institutional Review Board (IRB) of the University ofMichigan Medical Center indicating that they are aware of the investigationalaspects of the treatment and the potential risks.

Exclusion Criteria:

• Any serious disease, comorbidity or intercurrent illness which precludes delivery ofradiation 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 requiringantibiotics.

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 ascitesrequiring paracentesis, hepatic encephalopathy, hepatorenal syndrome orvariceal hemorrhage.

• Active gastrointestinal bleeding within 30 days of enrollment.