Sirtex Commences DOORwaY-90 Study for SIR-Spheres Therapy as First-Line Treatment of Unresectable HCC

May 10, 2021—Sirtex Medical announced that the first patient has been enrolled in the DOORwaY-90 study evaluating the safety and efficacy of selective internal radiation therapy using the company’s SIR-Spheres yttrium-90 (Y-90) resin microspheres in patients with unresectable hepatocellular carcinoma.

DOORwaY-90 is a United States–based multicenter, open-label, single-arm evaluation of the duration of response and objective response rate of SIR-Spheres. Cheenu Kappadath, PhD, and Armeen Mahvash, MD, are coprincipal investigators of the DOORwaY-90 study. The company announced FDA approval of the study in March 2021.

According to Sirtex, the study will enroll 100 patients with Barcelona Clinic Liver Cancer (BCLC) Stage A, B1, and B2 who are not eligible for resection or ablation at the time of study entry. Enrollment will be conducted at 15 academic and nonacademic sites.

The study will utilize and delineate personalized dosimetry treatment planning and define actionable post-treatment dosimetric verification for endpoint assessment, noted the company.

“It’s important for physicians to have confidence that their planned Y-90 dose is being delivered in the right amount and to the right place,” commented Douglas Murrey, MD, in the Sirtex press release. “The personalized dosimetry component of the DOORwaY-90 study will provide meaningful insights to advance our practice and patient outcomes.” Dr. Murrey is a Vascular and Interventional Radiologist at Inland Imaging Associates and Providence Sacred Heart Medical Center in Spokane, Washington, which enrolled the first patient in the study.