The first patient has been enrolled in DOORwaY-90, a study evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres Y-90 resin microspheres (Sirtex) in patients with unresectable hepatocellular carcinoma (HCC).
DOORwaY-90, which stands for “Duration of Objective Response with Arterial Y-90,” is the first prospective, US-based, multicentre, open-label, single arm study of its kind. The study will assess the duration of response and objective response rate of SIR-Spheres. It is being led by co-principal investigators Cheenu Kappadath and Armeen Mahvash (both The University of Texas MD Anderson Cancer Center, Houston, USA). Study enrollment is underway, with the first patient enrolled at Inland Imaging Associates and Providence Sacred Heart Medical Center in Spokane, USA.
“We are thrilled to enroll the first patient in DOORwaY-90,” comments Mark A Turco, global chief medical officer and EVP of research and development for Sirtex. “This clinical trial studying a heterogeneous population of patients with HCC using personalised dosimetry planning has the potential to advance the treatment of HCC patients worldwide. We are deeply thankful to every clinical investigator and patient who will be part of this ground-breaking journey.”
With a planned enrollment of 100 patients across 15 sites both academic and non-academic, DOORwaY-90 is enrolling 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. The study is unique because it is the first FDA-approved US-based prospective trial to utilise and delineate personalised dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment.
“It is important for physicians to have confidence that their planned Y-90 dose is being delivered in the right amount and to the right place,” says Douglas Murrey, vascular and interventional radiologist at Inland Imaging Associates and Providence Sacred Heart Medical Center in Spokane, USA. “The personalised dosimetry component of the DOORwaY-90 study will provide meaningful insights to advance our practice and patient outcomes.”
HCC is often diagnosed when potentially curative resection or transplantation is not feasible. SIRT has the potential to deliver a lethal dose of radiation to hepatic tumours, while sparing surrounding healthy liver tissue. In countries outside the USA, SIRT has been successfully used to bridge patients to transplantation or downstage HCC to within transplantation criteria or resection.