Woburn, Massachusetts | April 13, 2026
Sirtex Medical has announced groundbreaking results from its DOORwaY90 clinical study, demonstrating 100% local tumor control in patients with unresectable hepatocellular carcinoma (HCC) treated with SIR-Spheres® Y-90 resin microspheres. The pivotal, prospective, multicenter U.S. trial achieved a 99% overall response rate (ORR) and a 90% complete response (CR) rate, marking one of the most significant advancements in interventional oncology and liver-directed therapies. These results, presented at the Society of Interventional Radiology (SIR) Annual Meeting 2026, highlight the transformative potential of personalized dosimetry in radioembolization therapy and set a new benchmark for treating advanced liver cancer.
DOORwaY90 Trial Demonstrates Unprecedented Tumor Response
The DOORwaY90 study represents the first prospective, multicenter U.S. trial evaluating Y-90 selective internal radiation therapy (SIRT) using partition dosimetry in patients with unresectable HCC. The trial successfully met its co-primary endpoints, with all evaluable patients responding to treatment, resulting in complete local tumor control. Notably, 75% of responses were durable beyond six months, with a median duration of 295 days, underscoring the therapy’s long-lasting clinical benefit. These outcomes significantly exceed historical benchmarks for liver-directed therapies and position SIR-Spheres as a leading treatment option in advanced HCC management.
Personalized Dosimetry Enhances Efficacy and Safety
A key innovation in the DOORwaY90 study is the use of personalized dosimetry, which enables precise delivery of radiation doses tailored to individual patient anatomy and tumor characteristics. This approach allows clinicians to maximize tumor targeting while preserving healthy liver tissue, addressing one of the major challenges in liver cancer treatment. Importantly, more than 95% of patients maintained stable liver function at 12 months, demonstrating that high therapeutic efficacy can be achieved without compromising hepatic reserve. The ability to balance aggressive tumor control with safety represents a major advancement in precision interventional oncology.
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SIR-Spheres Strengthen Position in Liver Cancer Treatment
SIR-Spheres® Y-90 resin microspheres are currently the only FDA-approved radioembolization therapy for both unresectable hepatocellular carcinoma and metastatic colorectal cancer (mCRC) in the liver. The DOORwaY90 results further validate their role as a definitive liver-directed therapy, particularly for patients who are not eligible for surgical resection. By delivering targeted internal radiation directly to tumors, SIR-Spheres provide a minimally invasive alternative to conventional treatments, offering improved outcomes and quality of life for patients. These findings reinforce the growing importance of image-guided, minimally invasive therapies in modern oncology practice.
Clinical Impact and Future Outlook in Interventional Oncology
Hepatocellular carcinoma remains one of the most challenging cancers to treat, with limited options for patients with advanced or unresectable disease. The DOORwaY90 study demonstrates that radioembolization with personalized dosimetry can deliver exceptional clinical outcomes, potentially redefining treatment standards. As the adoption of precision medicine and targeted therapies continues to grow, innovations such as SIR-Spheres are expected to play a critical role in improving survival and expanding treatment options. Future research will likely focus on combining radioembolization with systemic therapies and immunotherapies, further enhancing its clinical impact.
The DOORwaY90 study results mark a major milestone in the evolution of liver cancer treatment, showcasing the power of precision-guided radiopharmaceutical therapies. With 100% tumor control, high response rates, and preserved liver function, SIR-Spheres represent a significant advancement in interventional oncology. These findings not only set a new benchmark for Y-90 therapy but also highlight the potential of personalized treatment approaches to transform patient outcomes in oncology.
Source: Sirtex Medical press release
