Inclusion Criteria:

- ECOG ≤ 2

- Histologically or cytologically diagnosed hepatocellular carcinoma, or diagnosis on
at least one cross-sectional imaging with the characteristic appearance of HCC (i.e.
liver lesion with arterial enhancement and portal venous washout)

- Decision to treat with single agent sorafenib at 400mg bid (dose reductions or
interruptions are permitted if side effects occur during treatment)

- No prior systemic chemotherapy or targeted therapy

- Child-Pugh liver function class A or B

- At least one untreated target lesion that can be measured in one dimension according
to RECIST

- Adequate organ functions

Exclusion Criteria:

- Prior systemic chemotherapy or molecularly targeted therapy

- Concurrent active malignancy

- Concomitant strong CYP3A4 induced or inhibitor at a therapeutic dose (see section
6.4.1)

- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent

- Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal
medical therapy)

- History of, or known brain metastases (skull metastases allowed), carcinomatous
meningitis, or leptomenigeal disease

- Major surgery (e.g. open abdominal therapy, pelvic, thoracic, orthopaedic or
neurosurgery) within 4 weeks of the date of first dose

- Local-regional treatment (i.e. percutaneous and trans-arterial procedures) within 4
weeks. Restaging CT or MRI scan must be repeated at least 4 weeks after
local-regional treatment and within 3 weeks before the date of first dose

- For patients treated with Yttrium (90Y) radiotherapy, a washout period of 2 months is
required.

- Evidence of severe or uncontrolled systemic disease or any concurrent condition which
in the investigator's opinion makes it undesirable for the patient to participate in
the study or which would jeopardize compliance with the protocol

- Pregnancy or breast feeding