The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of hepatocellular carcinoma (HCC)

- Histopathology confirmation may be waived in patients with a radiographically
identifiable liver mass in addition to known laboratory or clinical risk factors
for HCC, and/or an elevated alpha-fetoprotein (AFP) level

- No significant extrahepatic disease that may represent an imminent life-threatening
outcome

- No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiotherapy to the lungs on either the first yttrium-90 glass microspheres
(TheraSphere®) administration or with cumulative delivery of radiation to the lungs
over multiple treatments due to any angiographically uncorrectable flow to the
gastrointestinal tract

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- No hepatic dysfunction

- Bilirubin ≤ 2.0 mg/dL

- No vascular abnormalities or severe peripheral vascular disease that would preclude
angiography or selective visceral catheterization

- No pulmonary insufficiency

- No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the
stomach or duodenum after application of established angiographic techniques to stop
such flow

- No contraindications to angiography

- No contraindications to selective visceral catheterization

- No other condition or cormorbidity that would preclude study treatment

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 30 days
after study

PRIOR CONCURRENT THERAPY:

- At least 1 month since prior chemotherapy, radiotherapy, or surgery

- No other concurrent investigational agents or anticancer therapy for HCC