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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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Interventional Oncology Products

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.1,2,3,55,56

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  3. Hilgard P, Hamami M, Fouly AE, et al. Radioembolization with yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long-term survival. Hepatology 2010;52(5):1741–9.
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  6. Vouche M, Habib A, Ward TJ, et al. Unresectable solitary hepatocellular carcinoma not amenable to radiofrequency ablation: multicenter radiology-pathology correlation and survival of radiation segmentectomy. Hepatology 2014;60(1):192–201.
  7. Salem R, Lewandowski RJ, Kulik L, et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology 2011;140(2):497–507.
  8. Lewandowski RJ, Kulik LM, Riaz A, et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant 2009;9(8):1920–8.
  9. Kennedy A, Nag S, Salem R, et al. Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: a consensus panel report from the radioembolization brachytherapy oncology consortium. Int J Radiat Oncol Biol Phys 2007;68(1):13–23.
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  11. Pellerin O, Lin M, Bhagat N, et al. Can C-arm cone-beam CT detect a micro-embolic effect after TheraSphere radioembolization of neuroendocrine and carcinoid liver metastasis? Cancer Biother Radiopharm 2013;28(6):459–65.
  12. Kulik M, Carr B, Mulcahy M, et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology 2008 47(1): 71-81.
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  55. USA Package Insert – TheraSphere® Yttrium-90 Glass Microspheres – Rev. 14. Biocompatibles UK Ltd, a BTG International group company.
  56. Canadian Package Insert TheraSphereTM Yttrium-90 Glass Microspheres – K120615-022 Rev. 7.
 

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