TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

Inclusion Criteria:

• Patients newly diagnosed as HCC according to European Association for Study of theLiver 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 followingcriteria:

• The lesion can be accurately measured in at least one dimension according toRECIST criteria

• The lesion has not been previously treated with surgery, radiation therapy,radiofrequency ablation, percutaneous ethanol or acetic acid injection, orcryoablation.

• 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) Prothrombintime international normalized ratio < 1.5

• Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit ofnormal

• Ability to understand the protocol and to agree to and sign a written informed consentdocument

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 daysprior 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 betablockers 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 tocomply with treatment and study instructions.

• Substance abuse (current), psychological, or social conditions that may interferewith 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 (basedon medical history)