The study will evaluate and compare the safety and efficacy of TheraSphere vs. sorafenib in hepatocellular carcinoma patients with portal vein thrombosis
On 24 April, Nordion announced an additional randomised, multicentre phase III clinical trial for TheraSphere, the company’s yttrium-90 (Y-90) glass microsphere treatment for liver cancer.
The YES-P trial will be focused primarily in Europe, with additional locations to be identified globally, and is targeting enrolment of about 350 patients at approximately 24 sites. The trial will further evaluate the safety and efficacy of TheraSpherein the treatment of patients with portal vein thrombosis associated with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
Portal vein thrombosis, a complication in which a clot forms in one of the blood vessels feeding the liver, occurs in approximately 30 to 40% of HCC cases. The presence of portal vein thrombosis is a contraindication for most embolic therapies, but TheraSphere represents a safe alternative.
“Nordion is excited to directly address the important question of whether TheraSphere can extend the lives of this subgroup of HCC patients, where typical life expectancy remains unacceptably low,” said Mason Ross, Nordion’s vice president of Medical Affairs. “YES-P is our first major clinical trial that will be primarily conducted in Europe, thus supporting our commitment to increase our global clinical research footprint while building on the knowledge of how TheraSphere may improve survival compared to sorafenib.”
The trial will follow a two-armed design. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere, while patients in the other arm will receive sorafenib.
In the last 13 months, Nordion has also announced two additional phase III clinical trials for TheraSphere: STOP-HCC, involving patients with HCC, and EPOCH, involving patients with colorectal cancer whose disease has metastasised to the liver.