Locally Advanced Hepatocellular Carcinoma Clinical Trial
Official title:
A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
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).
This study will enroll 176 patients randomized in a 1:1 allocation ratio (88 in each arm) to one of the two arms. - Study arm: SIRT-Y90 + 1200mg atezolizumab + 15mg/kg bevacizumab - Control arm: SIRT-Y90 + placebos (IV) The patients will be recruited from up to 13 sites from the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group (subjected to feasibility studies and ethics approval). Proposed sites are in Singapore, China, South Korea, and Taiwan. ;
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