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Clinical Trial Information

Protocol TS-104 / NCT01887717


An open-label, prospective, multicenter, randomized, Phase III clinical trial evaluating yttrium-90 transarterial radioembolisation (TheraSphere) versus the standard of care (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT).29,30


RANDOMIZE TREATMENT GROUP

TheraSphere


CONTROL GROUP

Standard-of-care therapy: sorafenib


OBJECTIVE

To assess efficacy and safety of TheraSphere in comparison to sorafenib therapy in the treatment of patients with PVT associated with unresectable HCC.


ENDPOINTS

Primary: Overall survival
Secondary:Time to progression, time to worsening portal vein thrombosis, response rate, time to symptomatic progression, quality of life (FACT-hep), safety

 

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