The US Food and Drug Administration (FDA) have approved the DOORwaY90 study, a trial evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres yttrium-90 (Y-90) resin microspheres (Sirtex Medical) in patients with unresectable hepatocellular carcinoma (HCC).
Unique to other recently published Y-90 studies, DOORwaY90, which stands for “Duration of objective response with arterial Y-90,” is the first prospective, multicentre study to utilise and delineate personalised dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment. The study will assess the duration of response and objective response rate of SIR-Spheres.
Outside the USA, SIR-Spheres are indicated for the treatment of patients with advanced non-operable liver cancer, including HCC.
The DOORwaY90 study is being led by co-principal investigators Cheenu Kappadath and Armeen Mahvash (both University of Texas MD Anderson Cancer Center, Houston, USA). “We are honoured to participate in this important study that could greatly impact the treatment of HCC patients in the USA,” notes Mahvash. “We look forward to working closely with Sirtex in executing and reporting the findings of DOORwaY90.”
DOORwaY90 is a 15-centre, 100-patient, US-based, open label, single arm study run in accordance with Good Clinical Practice. The study population consists of 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. For each patient, an eligibility review committee will review diagnostic imaging and confirm final eligibility and treatment planning prior to treatment. Enrollment is expected to begin at the start of the second financial quarter of 2021.
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 tumors, 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.