HCC Clinical Studies

Hepatocellular carcinoma (HCC) is the world's sixth most commonly-diagnosed cancer and the second-leading cause of cancer deaths annually. Unfortunately, for patients with advanced HCC who are ineligible for liver transplant, surgery or radio-frequency ablation, and have failed to respond after multiple courses of transarterial chemotherapy (TACE), few proven treatments exist.

Beginning in 2010, Sirtex has collaborated with leading clinical investigators in France, Germany and Singapore on a series of three large clinical trials to study the effect of SIR-Spheres® Y-90 resin microspheres in advanced HCC.

Two of these studies (SARAH in France and SIRveNIB in Asia-Pacific) enrolled in total more than 820 patents in a head-to-head comparison of SIR-Spheres Y-90 resin microspheres with sorafenib, the standard of care for advanced HCC. Top-line results of these two studies were reported in oral presentations at European Association for the Study of the Liver (EASL) (April 2017) and American Society of Clinical Oncology (ASCO) (June 2017) respectively.

The third, which is the 420-patient sub-study of a pan-European study called SORAMIC, examines the effect of treating advanced HCC patients initially with SIR-Spheres Y-90 resin microspheres before initiating sorafenib versus sorafenib alone, with results to be reported in 2018.

Together, these three studies could lead to modifications in international treatment guidelines for advanced HCC.

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