In the SHARP trial, patients with uHCC included:
Child-Pugh class A (95%), class B (5%)
ECOG performance status 0-2
Portal vein invasion/extrahepatic spread (with or without)
Broad range of demographics
Europe and Australasia (88%)
North America (9%)
Central and South America (3%)
BCLC stage B and C
Unresectable
because of inadequate hepatic
reserve or tumor location
Inoperable because of
performance status or
comorbidity, local disease, or
local disease with minimal
extrahepatic disease only
HCC with metastatic
disease or extensive liver
tumor burden
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Patients who permanently discontinued sorafenib therapy due to toxicity or who were unable to tolerate sorafenib doses of 400 mg once daily were ineligible for the RESORCE trial3
STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
WARNING: HEPATOTOXICITY
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
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