Hepatocellular Carcinoma Clinical Trial
Official title:
A Two-arm Multi-stage (TAMS) Seamless Phase II/III Randomised Trial of Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC
This study evaluates the addition of nivolumab to TACE/TAE in the treatment of patients with intermediate stage hepatocellular carcinoma. All patients will receive TACE/TAE and half will receive nivolumab.
A significant proportion of HCC patients present with, or progress to, intermediate stage
disease and these patients are typically treated with transarterial chemo-embolisation (TACE)
or transarterial embolisation (TAE).
However, since TACE/TAE is generally a palliative therapy, it provides a potential backbone
for the addition of effective systemic therapies with the aim of improving survival outcomes.
Since TACE may liberate an abundance of tumour antigens and 'danger' signals, it may lend
itself to combination with immunotherapeutic strategies.
Nivolumab is a human monoclonal antibody. Nivolumab targets the programmed death-1 PD-1)
cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative
regulatory molecule expressed by activated T and B lymphocytes.
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