Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib

Inclusion criteria

• Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
• Disease must not be amenable to potentially curative surgery
• Without prior systemic nor transarterial treatment
• Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
• Child-Pugh stage A liver function
• ECOG performance 0-2
• Life expectancy longer than 12 weeks
• At least one measurable treatment lesion according to modified RECIST criteria
• Adequate haematological, hepatic and renal function

Exclusion criteria

• Contra-indications to TACE treatment:

• Main portal vein thrombosis or occlusion
• Evidence of biliary obstruction
• Presence of extra-hepatic disease
• Diffuse-type HCC
• Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
• Any form of prior transarterial therapy or systemic therapy for HCC.
• Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
• Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
• Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week