START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial
- 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
- 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.
- 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)