SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

Inclusion Criteria:

- must have a confirmed diagnosis of HCC.

- at least 18 years of age.

- must have a confirmed diagnosis of HCC either by histological confirmation or, in a
subject who exhibits a vascular liver mass in the presence of radiographically
apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 UI/ml.

- must present HCC that is not amenable to surgical resection or immediate liver
transplantation, or that is not optimally treatable with local ablative techniques
such as radio-frequency ablation due to its size, extent or presence of cirrhosis.

- must present measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension as greater than or equal to 10 mm with spiral CT
scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).

- must present with a whole-liver tumor burden of greater than or equal to 15% and less
than or equal to 70%

- must have an ECOG performance status of 2 or less.

- must have normal organ and marrow function

Exclusion criteria:

Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria
specific to the setting of this investigational study:

- hepatic artery directed therapy within the previous 6 months.

- chemotherapy within the previous 4 weeks

- have not recovered from adverse events due to agents administered previously

- Prior external hepatic radiation therapy for HCC, more than two prior systemic
chemotherapy regimes for HCC or any other concomitant therapy for HCC

- Currently receiving any other investigational agents for the treatment of their
cancer.

- Any extra-hepatic metastases other than metastatic disease found in the lung, bone
and/or abdominal lymph nodes that are not otherwise life limiting.

- Any other concurrent malignancy, except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease-free for at least five years.

- Uncontrolled intercurrent illness or psychiatric illness/social situations that would
limit compliance with study requirements.

- Any of the following contraindications to angiography and selective visceral
catheterization:

- Bleeding diathesis

- Severe peripheral vascular disease

- Portal hypertension with hepatofugal flow

- Female subjects who are pregnant or currently breastfeeding.

- Refusal or inability to use effective means of contraception in men or women of
childbearing potential.

- Current enrollment in any other investigational drug or device study.