Sirtex SIR-Spheres Evaluated in DOORwaY90 Pivotal Trial to Treat Unresectable HCC

April 13, 2026—Sirtex Medical announced that its landmark pivotal DOORwaY90 trial met its 12-month prespecified coprimary endpoints, demonstrating a 90% complete response rate and an overall response rate of 99%, as assessed by blinded independent central review. The prospective multicenter study is evaluating the company’s yttrium-90 (Y90) selective internal radiation therapy using partition dosimetry in patients with unresectable hepatocellular carcinoma (HCC). 

The DOORwaY90 results were presented as a late-breaking oral presentation at SIR 2026, the Society of Interventional Radiology’s annual scientific meeting in Toronto, Canada.

As reported in the Sirtex press release, all evaluable patients responded to treatment, resulting in 100% local tumor control. Responses were durable, with 75% lasting beyond 6 months and a median duration of 295 days. This finding reinforces the potential of SIR-Spheres Y90 resin microspheres to deliver sustained tumor responses while preserving liver function, stated the company.

Additionally, more than 95% of patients maintained stable liver function at 12 months, underscoring the ability of personalized dosimetry to achieve aggressive tumor response without compromising hepatic reserve, advised Sirtex.

“These 12-month results demonstrate the consistency of response achievable with personalized dosimetry,” commented DOORwaY90’s Coprincipal Investigator Armeen Mahvash, MD, in the company’s press release. “The high complete response rates, durability, and preservation of liver function observed in this study give physicians increased confidence in using radioembolization as a definitive, liver-directed treatment option.”

In the United States, SIR-Spheres Y90 resin microspheres are approved by the FDA for the treatment of both metastatic colorectal cancer of the liver and unresectable HCC, noted Sirtex Medical.