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Table 1 Patient eligibility criteria for SIRveNIB trial

From: Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma (SIRveNIB): study protocol for a phase iii randomized controlled trial

Inclusion criteria Exclusion criteria
• Unequivocal diganosis of locally advanced HCC without extrahepatic metastases
• Written informed consent provided
• Aged ≥18 years
• Patients with HCC that is not amenable to surgical resection, immediate liver transplantation, or that could be treated with local ablative techniques (e.g. radiofrequency ablation)
• Locally advanced HCC as defined by BCLC (B) intermediate stage or BCLC (C) advanced stage
• At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with spiral CT scan or MRI
• ECOG performance status 0–1
• Adequate haematological function: haemoglobin ≥9.5 g/dl, leukocytes ≥2500/mm3, platelets ≥80,000/mm3, INR ≤2.0
• Adequate kidney function: creatinine <2.0 mg/dl
• Adequate hepatic function: albumin ≥2.5 g/dl, bilirubin ≤2 mg/dl; ALP, AST or ALT ≤5 x ULN
• Liver cirrhosis Child-Pugh A–B (up to 7 points)
• Life expectancy of at least 3 months without active treatment
• Patients who have had >2 administrations of hepatic artery directed therapy
• Hepatic artery directed therapy <4 weeks before study entry
• Systemic chemotherapy for HCC, except previous adjuvant or neoadjuvant therapy given >6 months before enrollment
• Previous treatment with Sorafenib or VEGF inhibitors
• Previous radiotherapy for HCC or other malignancy
• Intractable ascites, or other clinical signs of liver failure
• Complete thrombosis of the main portal vein
• Extrahepatic metastases, except lung nodules <1 cm or local-regional lymph nodes <2 cm in greatest diameter
• Clinical signs of central nervous system metastases
• Other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥5 years
• Uncontrolled intercurrent illness
• Contraindications angiograghy to hepatic artery catheterisation: severe peripheral arterial disease precluding catheterisation, bleeding diathesis not correctable by standard forms of therapy, portal hypertension with hepato-fugal flow
• History of allergy to SIR-spheres, Soranefib or related agents
• Patient unable or unwilling to understand or sign the written informed consent
• Currently enrolled in another investigational therapeutic drug or device study
• Women, unless postmenopausal or surgically sterile are unwilling to practice effective contraception
• Men unwilling to use effective contraception during the course of the study
  1. ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate transaminase, CT computed tomography, MRI Magnetic resonance imaging, ECOG Eastern Cooperative Oncology Group, HCC hepatocellular carcinoma, INR international normalised ratio, ULN upper limit of normal