SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma

Inclusion criteria

• Male or female patients, aged ≥ 18 years
• Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
• Tumour characteristics as follows:

• Not more than 5 lesions
• If single, maximal diameter ≤ 10 cm
• If multiple, sum of maximal diameters ≤ 15 cm
• Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
• At least one quantifiable lesion on hepatic MRI
• Preserved liver function, corresponding to Child-Pugh class ≤ B-7
• ECOG performance status ≤ 2
• Life expectancy ≥ 12 weeks
• Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
• Willing and able to provide written informed consent

Exclusion criteria

• Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
• Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
• Serum transaminases > 5 x ULN
• Lung shunt > 20%
• Extrahepatic disease
• Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):

• History of variceal haemorrhage in past 2 years
• History of hepatic encephalopathy
• Platelets < 50.000 /ml
• WBC < 3.000 / ml
• Previous TIPSS procedure
• Portal vein occlusion or hepatofugal flow.
• Impaired liver function

• Total serum bilirubin > 2.0 mg / dL
• Serum albumin < 3.0 g /dl
• creatinine > 2 mg / dL
• Chemotherapy or other experimental therapy within preceding 4 weeks
• Previous TAE / TACE
• Previous radiation therapy to liver or lungs
• Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
• Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
• Any decompensated concomitant disease
• Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)