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STOP-HCC

Clinical Trial Information

Protocol TS-103 / NCT0155649


An open-label, prospective, multicenter, randomized, Phase III clinical trial evaluating yttrium-90 transarterial radioembolisation (TheraSphere™) in the treatment of patients with unresectable hepatocellular carcinoma (HCC).27,28


RANDOMIZE TREATMENT GROUP

TheraSphere™ prior to initiation of standard-of-care therapy: sorafenib


CONTROL GROUP

Standard-of-care therapy: sorafenib


OBJECTIVES

To evaluate the efficacy and safety of TheraSphere™ in patients with unresectable HCC in whom treatment with sorafenib is planned.


ENDPOINTS

Primary: Overall survival
Secondary: Time to progression, tumour response, time to symptomatic progression, quality of life (FACT-hep), time to untreatable progression, safety

Please visit the  THERASPHERE TRIALS WEBSITE for more details

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In the EU, TheraSphere™ is used in the treatment of hepatic neoplasia.
 

In Canada, TheraSphere™ may be used in the treatment of hepatic neoplasia patients who have appropriately positioned arterial catheters.
 
Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects were mild to moderate in severity and were manageable or resolved over time. For details on rare or more severe adverse effects, please refer to the TheraSphere™ Instructions for Use at www.therasphere.com. 2,3,47,48
 
 

 
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