Phase II Study Therasphere® (Yttrium-90) in Combination With Systemic Therapy in Patients With High-risk Hepatocellular Carcinoma
Northwestern University
Summary
The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.
Description
PRIMARY OBJECTIVES: I. To compare Progression Free Survival (PFS) in patients with advanced HCC who receive Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment ( lenvatinib or cabozantinib, Arm B). For ARM B, \[patients will receive Lenvatinib. If they have prior history of treatment with Lenvatinib, then can be given Cabozantinib\].. SECONDARY OBJECTIVES: I. To compare the Time to Progression (TTP) in patients with advanced HCC who receive Immunotherapy combination compared to TKI following Y90. II. To compare the Objective Response Rate (ORR…