Main

Inclusion Criteria:

- Advanced stage hepatocellular carcinoma

- Patients exhibiting progressive disease under Sorafenib treatment

- Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more
than 7 will be included

- ECOG performance status 0, 1 or 2

- Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg
per day for at least 8 weeks

Main Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
tumors (Ta, Tis and T1) - any cancer curatively treated > 3 years prior to entry is
permitted

- Renal failure requiring hemo- or peritoneal dialysis

- Known central nervous system (CNS) tumors including symptomatic brain metastasis

- Child-Pugh index class B in combination with more than slight ascites or hepatic
encephalopathy > Grade I

- Pregnant or breastfeeding women

- Sorafenib intolerance

- Major surgery within the last 4 weeks