Sirtex received an investigational device exemption from the FDA to conduct the trial. The trial is actively recruiting patients at Thomas Jefferson University’s Kimmel Cancer Center in Philadelphia, and the company expects to open patient recruitment at additional sites in the coming months.
A total of 40 participants will be enrolled over a period of 24 months. Eligible patients must be 18 years or older and have documented hepatocelluar carcinoma (HCC) disease confined to the liver. The primary objective of the study is to evaluate the effect of SIR-Spheres microspheres on survival rates in patients with HCC. The trial will also assess treatment safety, time-to-disease progression, health-related quality of life and tumor response to treatment.
SIR-Spheres microspheres are currently FDA approved for the treatment of unresectable metastatic liver tumors from primary colorectal cancer.