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

Inclusion Criteria11

• 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.