Inclusion criteria | Exclusion criteria |
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• Unequivocal diganosis of locally advanced HCC without extrahepatic metastases • Written informed consent provided • Aged ≥18 years • Patients with HCC that is not amenable to surgical resection, immediate liver transplantation, or that could be treated with local ablative techniques (e.g. radiofrequency ablation) • Locally advanced HCC as defined by BCLC (B) intermediate stage or BCLC (C) advanced stage • At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with spiral CT scan or MRI • ECOG performance status 0–1 • Adequate haematological function: haemoglobin ≥9.5 g/dl, leukocytes ≥2500/mm3, platelets ≥80,000/mm3, INR ≤2.0 • Adequate kidney function: creatinine <2.0 mg/dl • Adequate hepatic function: albumin ≥2.5 g/dl, bilirubin ≤2 mg/dl; ALP, AST or ALT ≤5 x ULN • Liver cirrhosis Child-Pugh A–B (up to 7 points) • Life expectancy of at least 3 months without active treatment | • Patients who have had >2 administrations of hepatic artery directed therapy • Hepatic artery directed therapy <4 weeks before study entry • Systemic chemotherapy for HCC, except previous adjuvant or neoadjuvant therapy given >6 months before enrollment • Previous treatment with Sorafenib or VEGF inhibitors • Previous radiotherapy for HCC or other malignancy • Intractable ascites, or other clinical signs of liver failure • Complete thrombosis of the main portal vein • Extrahepatic metastases, except lung nodules <1 cm or local-regional lymph nodes <2 cm in greatest diameter • Clinical signs of central nervous system metastases • Other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥5 years • Uncontrolled intercurrent illness • Contraindications angiograghy to hepatic artery catheterisation: severe peripheral arterial disease precluding catheterisation, bleeding diathesis not correctable by standard forms of therapy, portal hypertension with hepato-fugal flow • History of allergy to SIR-spheres, Soranefib or related agents • Patient unable or unwilling to understand or sign the written informed consent • Currently enrolled in another investigational therapeutic drug or device study • Women, unless postmenopausal or surgically sterile are unwilling to practice effective contraception • Men unwilling to use effective contraception during the course of the study |