A multicenter, open-label, single-arm study of the safety and antitumoral efficacy of nivolumab in combination with selective internal radiation therapy (SIRT) using SIR-Spheres for the treatment of patients with hepatocellular carcinoma that are candidates for locoregional therapies.

Overview

No summary available.

Registry

who.int

Start Date

June 9, 2017

End Date

April 30, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Age 18\-years\-old or above
•Diagnosis of HCC based on histology or non\-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded.
•Chronic liver disease absent, non\-viral or due to hepatitis C or B virus infection. Subjects with chronic HBV infection must be on effective antiviral therapy
•Preserved liver function (without cirrhosis or with compensated cirrhosis in Child Pugh Class A).
•ECOG performance status 0 or 1
•Willing to have a liver biopsy pre\-treatment
•Considered candidates for locoregional therapy using SIR\-Spheres based on
•the absence of extrahepatic disease.
•unsuitability for liver resection or transplantation, or percutaneous ablation
•considered not good candidates for TACE because they have:

•Any history of hepatic encephalopathy
•Any prior (within 1 year) or current clinically significant ascites.
•Any history of clinically meaningful variceal bleeding within the last three months.
•Active coinfection with both hepatitis B and C or hepatitis D infection in subjects with hepatitis B
•Occlusive main trunk portal vein thrombosis or absence of intrahepatic portal blood flow if patient carries a portocaval shunt.
•Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
•Any active autoimmune disease.
•Any severe organ disease
•Prior therapy with any drug specifically targeting T\-cell costimulation or checkpoint pathways.
•Prior organ allograft or allogeneic bone marrow transplantation