A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

Inclusion Criteria:

- 18 yrs of age or older

- Diagnosis of Hepatocellular Carcinoma

- Portal Vein Thrombosis

- ECOG performance < 2

->4 weeks since prior radiation, surgery or chemotherapy.

- Life expectancy > 3 months

- Able to provide written informed consent process in accordance with institutional
review boards guidelines.

Exclusion Criteria:

- Contraindications to angiography and selective visceral catheterization.

- Evidence of blood flow to the lung from the liver greater than 16.5 mCi

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

- Significant extrahepatic disease.

- Severe liver disfunction of pulmonary insufficiency.

- Active uncontrolled infection.

- Significant underlying medical or psychiatric illness.

- Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or
if they have a co-morbid disease or condition that would preclude safe delivery of
TheraSphere treatment and place the patient at undue risk.