Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.
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)