Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

Inclusion Criteria:

* Age ≧ 18
* life expectancy \> 12 weeks
* Histologically diagnosed HCC, OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis. A clinically diagnosed HCC should fulfill ALL the criteria below

  * Chronic hepatitis B or C and/or evidence of liver cirrhosis.
  * Presence of hepatic tumour(s) with image findings compatible with HCC, and no evidence of other gastrointestinal tumours
  * A persistent elevation of serum AFP \>= 400 ng/ml without any evidence of an existing α-fetoprotein-secreting germ cell tumour
* Child-Pugh score ≦ 7
* BCLC B
* The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning.
* The target lesion must not have been previously treated with local therapy
* The patient must not be a candidate for surgical resection or ablation of the tumour. Size of largest tumor ≦10cm in largest dimension
* Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
* Local therapy must have been completed at least 4 weeks prior to baseline scan.
* ECOG performance status 0 or 1
* Hb ≧ 9g/dL,
* Absolute neutrophil count \> 1000/mm3
* Platelet count ≧ 60x109/L
* Adequate clotting function: INR \< 1.5
* Hepatic: AST or ALT \< 5 X ULN
* Renal: serum creatinine \< 1.5 x ULN
* Bilirubin ≦ 3mg/dL
* The patient must give written, informed consent

Exclusion Criteria:

* Tumor factors

  * Presence of extrahepatic metastasis
  * Predominantly infiltrative lesion
  * Diffuse tumor morphology with extensive lesions involving both lobes.
* Vascular complications

  * Hepatic artery thrombosis, or
  * Partial or complete thrombosis of the main portal vein, or
  * Tumor invasion of portal branch of contralateral lobe, or
  * Hepatic vein tumor thrombus, or
  * Significant arterioportal shunt not amenable to shunt blockage
* Liver function

  * Advanced liver disease: ascites, hepatic encephalopathy
  * Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
* Others

  * Pregnant or lactating women.
  * Active sepsis or bleeding.
  * Hypersensitivity to intravenous contrast agents.
  * The patient has received prior treatment for HCC target lesion.
  * History of cardiac disease

    * Congestive heart failure \> NYHA class 2; active coronary artery disease
    * Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  * Hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management.
  * Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
  * Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
  * Impairment of swallowing that would preclude administration of sorafenib.
  * The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
  * 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 \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
  * Any active clinically serious infections (\> grade 2 NCI-CTCAE ver 3.0)
  * HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)