Clinical Trials

Inclusion Criteria:

• Adult subjects of all ages, both sexes and all races will be included in this study.
• Subjects must be 18 years of age or older.
• Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
  • Biopsy proven HCC or:
    • A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic subjects;
    • ≥ 2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.
• Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
• Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
• Subjects must be eligible per standard of care for either TACE or SBRT procedures.
• Subjects must have a life expectancy of at least 12 weeks.
• Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .
• Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 8.
• Patients must have adequate organ function within 2 weeks of enrollment.
  • Bone marrow:
    • Platelets ≥ 30,000/mm^3.
  • Renal:
    • BUN ≤ 40 mg/dl; creatinine ≤ 2.0 mg/dl .
  • Hepatic:
    • INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason.
  • Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract; e.g., primary sclerosing cholangitis).
• Patients uninvolved liver volume will be estimated and must be > 700ml.
• Patients must have a Zubrod performance status of ≤ 2.
• Patients who are sexually active must agree to the use of contraception throughout the duration of the study.

Exclusion Criteria:

• Bone marrow: Platelets ≥ 30,000/mm^3
• Renal: BUN ≤ 40 mg/dl; creatinine ≤  mg/dl
• Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason.
• Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract; e.g., primary sclerosing cholangitis).
• Patients’ uninvolved liver volume will be estimated and must be > 700ml.
• Patients must have a Zubrod performance status of ≤ 2.
• Patients who are sexually active must agree to the use of contraception throughout the duration of the study.

Exclusion Criteria:

• Subjects in a “special category” as designated by FDA and the Canadian Institutes of Health or Canadian Panel on Research Ethics including subjects younger than 18, pregnant women, and prisoners.
• Refractory ascites that requires paracentesis for management.
• Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
• History of prior radiation to the liver.
• Evidence of metastatic disease.
• Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).
• Untreated varices at high risk of bleeding.
• Bile duct occlusion or a prior diagnosis of an incompetent papilla.
• Acute infection.
• Uncorrectable bleeding disorder.
• Leukopenia, ANC < 1000/ul.
• Hepatic encephalopathy.
• Portal vein thrombosis.