TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

Inclusion Criteria:

* Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
* BCLC stage A or B
* Child-Pugh class A or B (Child-Pugh score 7)
* ECOG performance status of 0
* Patients must have at least one tumor lesion that meets both of the following criteria:

  * The lesion can be accurately measured in at least one dimension according to RECIST criteria
  * The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  * 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.
* Haematology:Absolute neutrophil count (ANC) \> 1 x 109/L, Platelet count \> 40 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5
* Biochemistry:Total bilirubin \< 2 mg/dL Serum creatinine \< 1.5 x the upper limit of normal
* Ability to understand the protocol and to agree to and sign a written informed consent document

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

  * Renal failure requiring hemo- or peritoneal dialysis
  * 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.
  * Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
  * The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
  * Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  * 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)