A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

Inclusion Criteria:

- Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation
criterion may be waived in patients with a radiographically identifiable liver mass
with known laboratory or clinical risk factors for cancer or elevated tumor markers
such as AFP (clinical diagnosis)

- Surgical evaluation must conclude the patient is not a candidate for resection or
ablation.

- ECOG Performance Status Score 0 - 2.

- Age 18 years or older.

- Able to comprehend and provide written informed consent in accordance with
institutional and federal guidelines.

Exclusion Criteria:

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

- Absolute granulocyte count less than or equal to 1,500/ul

- Uncorrected Platelet count less than or equal to 75,000/ul

- Serum creatinine greater than or equal to 3.0 mg/dl

- Serum bilirubin greater than or equal to 2.0 mg/dl

- Any of the following contraindications to angiography and selective visceral
catheterization, 1.)History of severe allergy or intolerance to any contrast media,
narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual
forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude
catheterization.

- Portal hypertension with portal venous shunt away from the liver.

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiation to the lungs on either: 1) first TheraSphere® administration; or 2)
cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.

- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after
application of established angiographic techniques to stop such flow.

- Significant extrahepatic disease representing an imminent life-threatening outcome.

- Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency
(requiring continuous oxygen therapy).

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness.

- Pregnant women may not participate.

- Children may not participate due to lack of clinical experience.