A prospective, multicenter, open-label, clinical trial design to evaluate the safety and efficacy of 90Y resin microspheres for treatment of unresectable hepatocellular carcinoma (HCC): DOORwaY90

Presenter: Armeen Mahvash MD | The University of Texas Anderson Cancer Center Background: HCC is often diagnosed when potentially curative resection or transplantation not feasible. Selective internal radiation therapy (SIRT) with 90Y resin microspheres (SIR-Spheres®) an established locoregional treatment option for unresectable regulatory approval outside the USA. SIRT has potential to deliver a lethal dose hepatic tumors, while sparing surrounding healthy liver tissue. been successfully used bridge patients downstage within criteria resection. DOORwaY90 designed evaluate safety and effectiveness as first-line in unablatable HCC. unique because it will be first US registration trial utilize delineate personalized dosimetry planning define actionable post-treatment dosimetric verification endpoint assessment. Methods: prospective, multicenter (up 15 centers), open label, single arm study. For each patient, eligibility review committee diagnostic imaging confirm final planning. Key include unresectable/unablatable (LI-RAD 4/5 by histology), BCLC stage A, B1, B2, maximal tumor diameter ≤8 cm, sum all diameters ≤12 at least one ≥2 cm (long axis) per RECIST, CPS30% total volume must disease free spared SIRT. Target mean lungs 40% DoR ≥6 months ≥60% responders. Secondary endpoints: grade ≥3 toxicity (CTCAE v5.0), QoL (FACT-Hep EQ-5D-5L) incidence post recruitment 100 patients. study conducted accordance Declaration Helsinki approved ethics committee. At time submission, enrollment.