Radiation oncology firm Sirtex Medical said that it has received U.S. Food and Drug Administration (FDA) approval to begin a multicenter trial to assess its SIR-Spheres yttrium-90 (Y-90) microspheres as a treatment for unresectable advanced hepatocellular carcinoma (HCC).
The prospective trial, called the "Duration of Objective Response with Arterial Y-90 (DOORwaY90) study," will evaluate the safety and efficacy of using the company's SIR-Sphere Y-90 resin microspheres to perform selective internal radiation therapy (SIRT) in adults with unresectable HCC.
The trial is the company's first prospective, multicenter study to utilize and delineate personalized dosimetry plans and to define actionable post-treatment dosimetric verification for endpoint assessment, according to the vendor. DOORwaY90 will also track the duration of response and objective response rate for SIR-Spheres.
Led by co-principal investigators Cheenu Kappadath, PhD, and Dr. Armeen Mahvash of the University of Texas MD Anderson Cancer Center, the open-label, single-arm study will include 15 centers and 100 patients. Enrollment is expected to begin early in the second quarter, Sirtex said.
The company noted that SIR-Spheres has been cleared outside of the U.S. to treat patients with advanced nonoperable liver cancer, including HCC. The new study could potentially expand the current FDA-approved indication for SIR-Spheres, Sirtex said.
