Nordion has received FDA approval to conduct a phase III clinical trial for TheraSphere under an Investigational Device Exemption (IDE). The trial will examine the safety and effectiveness of TheraSphere when the treatment is added to standard kinase inhibitor therapy in patients with unresectable hepatocellular carcinoma.
TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the main artery of the patient's liver through a catheter, which allows the treatment to be delivered to the tumor via blood vessels, according to the Ottawa-based Nordion.
The trial, known as the STOP-HCC study, is a randomized phase III clinical trial that will take place at up to 40 sites globally, and will enroll approximately 400 patients. The two-arm trial will examine a number of safety and efficacy endpoints. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere prior to receiving standard kinase inhibitor therapy, while in the other arm only the standard kinase inhibitor therapy will be used, said the company.