Prospective, multicenter, open-label clinical study to evaluate the efficacy and safety of TheraSphere™ followed by Durvalumab (Imfinzi®) with Tremelimumab (Imjudo®) for hepatocellular carcinoma (HCC)
Study short title: ROWAN

PI: Dr. Vincenzo Mazzaferro 

Global, open-label, prospective, multicenter Phase II study designed to evaluate the safety and efficacy of TheraSphere administered prior to the initiation of Durvalumab with Tremelimumab in patients with hepatocellular carcinoma (HCC) who are not candidates for surgical resection, thermal ablation, or liver transplantation at the time of study entry. 

Experimental: TheraSphere followed by Durvalumab and Tremelimumab 

• Device: TheraSphere – TheraSphere Y-90 glass microsphere therapy. TheraSphere Y-90 glass microspheres administered via the hepatic artery during the index procedure. 
• Drug: Immunotherapy with Durvalumab (Imfinzi) – 1500 mg every 4 weeks, for up to 18 months or until confirmed disease progression, unacceptable toxicity, withdrawal from the study, or early termination by the sponsor. 
• Drug: Immunotherapy with Tremelimumab – 300 mg, single administration. 
• Treatment regimen: TheraSphere followed by a single administration of Tremelimumab and Durvalumab, with monthly Durvalumab maintenance for up to 18 months.