This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab \[study arm\], versus SIRT-Y90 followed by placebo \[control arm\] in patients with locally advanced Hepatocellular Carcinoma (HCC).
Unequivocal diagnosis of HCC (AASLD 2010 diagnostic criteria or histology) that is locally advanced without extra-hepatic metastases but with significant tumor burden, i.e.,
Tumor confined to the liver that is beyond the up-to-7 criteria, and/or
Tumor with vascular invasion VP 1-3 and/or Vv 1-2 (at the discretion of site investigator) Both local and central assessments are required at screening, prior to any study treatment. Sites are required to send all CT/MRI images for central imaging review. The central assessment result will be made known to sites and will take precedence in determining a patient's study eligibility in case of a discrepancy between local and central review.
Aged 21 years old and above of either gender.
Patient not eligible for SIRT-Y90 treatment after assessment with macro-aggregated albumin labeled with technetium-99 (MAA) scan on SPECT/CT or planar imaging.
Patients who have SAE > grade 3 within 4 weeks after receiving SIRT-Y90. For patients who experience SAE > grade 3 after receiving SIRT-Y90 (1st or 2nd administration), the duration between the SIRT-Y90 dose and randomization and/or 1st and 2nd SIRT-Y90 dose (for two-staged delivery) may be extended by an additional 4 weeks to re-assess the patient's eligibility.
Patients who have had >2 administrations of hepatic artery directed therapy.
Patients who have had hepatic artery directed therapy done <4 weeks prior to date of ICF signing.
National Cancer Centre, Singapore
Lead sponsor
Hoffmann-La Roche
Collaborator
Sirtex Medical
Collaborator
Singapore Clinical Research Institute
Collaborator