A Multi-Center, Placebo-Controlled Randomized Pilot of the Effect of Sorafenib on Portal Pressure in Patients With Cirrhosis, Portal Hypertension and Hepatocellular Carcinoma Treated With Ablative Therapy and/or Transarterial Chemoembolization

Inclusion Criteria

- Age 20-75 years

- Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver,
splenomegaly and/or collaterals

- HCC proven histologically or diagnosed following the AASLD criteria if biopsy not
feasible or refused by the patient

- HCC must be unresectable and within UCSF criteria (single tumor ≤ 6.5 cm diameter,
or, if multiple lesions, maximum diameter of the largest lesion ≤ 4.5 and total
tumor diameter ≤ 8 cm (23))

- CPT score <9 (that is all Child A and Child B with a score of 7 or 8)

- Complete response to treatment with RFA (including that performed laparoscopically)
or TACE or a combination of the above as defined by radiologic criteria (hepatoma
protocol MRI or CT scan performed 4-6 weeks after the procedure).

- No more than two ablative procedures prior to enrollment

- Presence of portal hypertension, as defined by HVPG of >5 mmHg

- EGD for variceal screening performed within 6 months of entry into the study unless
the patient is already on a stable dose of a non selective beta-blocker (adjusted to
obtain a heart rate of 55-60 bpm) or treated with variceal band ligation.

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study
participation. Men should use adequate birth control for at least three months after
the last administration of sorafenib.

- Signed informed consent