The SIRSA, SIRveNIB, SARAH and SORAMIC Clinical Trials - ITR8
The SIRSA, SIRveNIB, SARAH and SORAMIC Clinical Trials - ITR8
The SIRSA, SIRveNIB, SARAH and SORAMIC Clinical Trials - ITR8
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A Phase III <strong>Clinical</strong> Trial of Intra‐arterial <strong>The</strong>raSphere® in the<br />
Treatment of Patients with Unresectable Hepatocellular<br />
Carcinoma: STOP-HCC 1<br />
• PI: Riad Salem<br />
• R<strong>and</strong>omized Phase III<br />
– Multicenter; ; international<br />
– N=400 approximately<br />
– Unresectable HCC<br />
• Kinase Inhibitor +/- <strong>The</strong>raSphere<br />
• EEndpoints d i t<br />
• Primary<br />
• Overall survival (OS)<br />
• Secondary<br />
• Safety<br />
R<br />
A<br />
N<br />
D<br />
O<br />
M<br />
I<br />
Z<br />
E<br />
Treatment<br />
Gro Groupp<br />
<strong>The</strong>raSphere<br />
prior to initiation<br />
of St<strong>and</strong>ard-of-<br />
Care therapy:<br />
kinase inhibitor Endpoints<br />
�Primary<br />
oOS<br />
�Secondary<br />
oSafety<br />
Control Group<br />
Planned<br />
St<strong>and</strong>ard-of-Care<br />
therapy: kinase<br />
inhibitor<br />
1 Nordion Phase III <strong>Clinical</strong> <strong>Trials</strong>:<br />
• conducted under Investigational Device Exemption (IDE)<br />
32
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