Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma

Inclusion -

   - Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension.

      - 800 cc of uninvolved liver

      - Patients may have additional hepatic lesions if they are <3cm and can be treated
      with TACE or RFA.

   - Age > 18 years old

   - Albumin > 2.4 g/dL.

   - Total bilirubin < 3 mg/dL.

   - INR ≤ 1.5.

   - Creatinine < 2.0 mg/dL.

   - Confirmed hepatocellular carcinoma by one of the following:

      - Histopathology

      - Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a
      lesion >2 cm with arterial hypervascularization

      - One radiographic technique that confirms a lesion >2 cm with arterial
      hypervascularization and an elevated AFP

   - Hepatic lesion in patients for whom surgical resection is not possible or would not
   result in an opportunity for cure

   - Tumor(s) <10cm

   - Eastern Clinical Oncology Group performance status 0, 1 or 2

   - No prior surgery, chemotherapy, or radiation for the current tumor

   - Patients placed on the liver transplant registry are eligible for this trial, but will
   be withdrawn from the protocol if they receive liver transplantation.

   - TACE done prior to study enrollment is allowed if there were no more than 3 procedures
   within an 18 week period and SBRT can begin within 12 weeks of the last TACE
   procedure.

Exclusion -

   - Prior radiotherapy to the upper abdomen

   - Prior TACE, RFA, or liver transplant

   - Tumor(s) ≥ 10cm

   - Large esophageal varices without band ligation

   - Active GI bleed or within 2 weeks of study enrollment

   - Ascites refractory to medical therapy

   - Contraindication to receiving radiotherapy

   - Women who are pregnant

   - Administration of any systemic cytotoxic agents within the last 12 months

   - Presence of extrahepatic metastases

   - Participation in another concurrent treatment protocol