Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)
- Patients newly diagnosed as HCC according to European Association for Study of the
- BCLC stage 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
- The lesion can be accurately measured in at least one dimension according to
- The lesion has not been previously treated with surgery, radiation therapy,
radiofrequency ablation, percutaneous ethanol or acetic acid injection, or
- 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
- Ability to understand the protocol and to agree to and sign a written informed
- 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.
- 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
- 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)