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Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04541173
Phase: Phase II
Principal Investigator: Parikh, Nainesh
A Randomized Phase II Study of Atezolizumab and Bevacizumab with Y-90 TARE in Patients with Unresectable Hepatocellular Carcinoma (HCC)
This is an open-label phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable intermediate stage HCC.
Primary Objective * Assess progression free survival (PFS) per RECIST 1.1 Secondary Objectives * Assess safety and tolerability of Y-90 TARE combined with atezolizumab and bevacizumab in patients with HCC. * Assess the progression free survival (PFS) per mRECIST * Assess Time to Progression (TTP) per RECIST 1.1 and mRECIST * Assess Overall response rate (ORR) per RECIST 1.1 and mRECIST * Assess Overall survival (OS) * Evaluate PROs of physical functioning, role functioning, social functioning, and global health status/quality of life experienced by patients receiving Y-90 TARE and bevacizumab plus atezolizumab treatment.
Immunotherapy; Radiotherapy
Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); Not Applicable (); Yttrium-90 ()
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