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Table 1 Patient eligibility criteria for SARAH trial

From: Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial

Inclusion criteria Exclusion criteria
• Written informed consent provided • Other primary tumour except for basal cell carcinomas or superficial bladder cancers
• Aged ≥18 years
• Histologically or cytologically confirmed diagnosis, or AASLD criteria for the diagnosis, of HCC and at least one measureable lesion on CT according to RECIST criteria • Extrahepatic metastases except non-specific pulmonary tumours <1 cm and abdominal lymph nodes <2 cm
• Previously treated advanced HCC (excluding chemoembolisation*)
• Patients not eligible for surgical resection, liver transplantation or thermoablation who have advanced HCC according to the Barcelona criteria (stage C), with or without portal invasion OR patients with recurrent HCC (new lesion in a different place) after surgical or thermoablative treatment who are not eligible for any other treatment; OR patients in whom chemoembolisation has failed after two rounds – treatment failure is defined as the absence of objective response in the treated nodule after two rounds (objective response according to the modified RECIST criteria and/or EASL criteria) • Advanced liver disease with a Child-Pugh score > B7 or active digestive haemorrhage or encephalopathy or refractory ascites
• Pregnant or breastfeeding women
• Allergy to contrast agents
• Contraindication to hepatic artery catheterisation, such as severe peripheral arterial disease precluding catheterisation
• Mental illness or other psychological disorder affecting the informed consent
• Patient unable or unwilling to comply with the treatment and follow-up required by the study
• Unable to take oral medication
• ECOG performance status ≤1
• Adequate haematological function: haemoglobin ≥9 g/100 mL, neutrophils ≥1,500/mm3, platelets ≥50,000/mm3
• Adequate kidney function: creatinine <150 μmol/L
• Bilirubin ≤50 μmol/l, AST or ALT ≤5 x ULN, INR ≤1.5
• If liver cirrhosis, Child-Pugh A-B7
• Affiliated to a social security scheme or beneficiary
  1. *Patients who have not responded to chemoembolisation but who meet the other selection criteria will be included in this study. AASLD, American Association for the Study of Liver Diseases; ALT, alanine aminotransferase; AST, aspartate transaminase; CT, computed tomography; EASL, European Association for the Study of the Liver; ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma; INR, international normalised ratio; RECIST, response evaluation criteria in solid tumours; ULN, upper limit of normal.