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

Launched by SIRTEX MEDICAL · Mar 20, 2009

Keywords

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Gender

ALL

Eligibility criteria

• 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)