Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study

Prior treatment

• Previous SIRT
• Previous systemic treatment for HCC within 4 weeks before radioembolization
• More than 2 previous transcatheter arterial chemoembolization (TACE) (or embolization), in the area to be treated

Other illness

• Chronic respiratory insufficiency history

Lab values

• Inadequate haematological, hepatic, renal, thyroid and coagulation functions: Haemoglobin < 8,5 g/dl, Granulocytes < 1500/mm3, Platelets< 50 000 /mm3, Bilirubin level ≥ 35 µmol/l, Transaminases > 6 UNL, Creatinine > 1,5 UNL, TSH < 0.2 µUI/L

Other

• Lung shunt >20%
• Poor tumor targeting
• Ascites (even if only radiological)
• Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
• Other neoplasia except if complete remission from at least one year
• Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
• Know hemophilia with exophytic tumor > 1 cm
• Extra-hepatic metastasis except hilum node < 2 cm

• Age ≥ 18 year
• ECOG Performance Status 0-1
• Hepatocellular Carcinoma with histological diagnosis or non-invasive diagnosis according to AASLD criteria
• Non operable and not accessible to ablation therapy
• At least one measurable lesion using mRECIST
• Tumor involvement <50% of the liver
• BCLC classification A to C
• Compensated cirrhosis (Child Pugh A only), if cirrhosis present
• Patient information and signature of informed consent or legal representative