SIR-Spheres (yttrium-90 microspheres)

P=N/A, N=100, Enrolling by invitation, GrandPharma (China) Co., Ltd.

P=N/A, N=100, Active, not recruiting, Sirtex Medical | Recruiting --> Active, not recruiting

P=N/A, N=6, Terminated, Medical University of South Carolina | Active, not recruiting --> Terminated; Enrollment closed by internal scientific review committee due to slow accrual.

P=N/A, N=100, Recruiting, Sirtex Medical | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Oct 2025

P1, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

P2, N=176, Recruiting, National Cancer Centre, Singapore | Trial completion date: Nov 2025 --> Oct 2026 | Trial primary completion date: Jan 2024 --> Apr 2025

P1, N=32, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=0, Withdrawn, Emory University | N=50 --> 0 | Not yet recruiting --> Withdrawn

In HCC patients receiving treatment, TARE using Y-90 resin microspheres may achieve comparable effectiveness outcomes compared with AB.

P=N/A, N=200, Not yet recruiting, GrandPharma (China) Co., Ltd.

Patients above 18 years old treated with Y90 SIRT (SIR-Spheres®, Sirtex Medical, USA) between 1st January and 1st May 2019 at National Cancer Centre Singapore (NCCS) and Singapore General Hospital (SGH) were included... We observed excellent clinical survival outcomes in HCC patients out of Milan Criteria treated with Y90 SIRT with a low complication rate. An absorbed dose of > 150 Gy is desired for better overall survival.

The ICER was mostly influenced by parameters defining the sorafenib overall survival curve and SIRT had a 73% probability of being cost-effective at a willingness-to-pay threshold of R$135,761 per QALY (three times the per-capita gross domestic product in Brazil). Overall, sensitivity analyses confirmed the robustness of the results indicating that SIRT with Y-90 resin microspheres is cost-effective compared with sorafenib.LimitationsA rapidly evolving treatment landscape in Brazil and worldwide, and the lack of local data for some variables were the main limitations.ConclusionsSIRT with Y-90 resin microspheres is a cost-effective option compared with sorafenib in Brazil.

The Bolondi subgroup classification stratifies OS, PFS and development of toxicity in patients treated with resin Y-90 microspheres. OS in subgroup 1 approaches 2.5 years and Grade 3 or greater hepatic toxicity profile in subgroups 1-3 is low.

P4, N=5, Recruiting, Sirtex Medical

P2, N=50, Not yet recruiting, Emory University | Initiation date: Sep 2022 --> Dec 2022

P2, N=50, Not yet recruiting, Emory University | Initiation date: Apr 2022 --> Jul 2022

P2, N=50, Not yet recruiting, Emory University

TARE using SIR-Spheres may achieve similar TTD in QOL compared with atezolizumab-bevacizumab, as the analyses found no statistically significant differences between these two interventions. Both TARE using SIR-Spheres and atezolizumab-bevacizumab seem to be more efficacious than sorafenib in maintaining QOL.

P=N/A, N=6, Active, not recruiting, Medical University of South Carolina | Recruiting --> Active, not recruiting | N=24 --> 6 | Trial primary completion date: Dec 2021 --> May 2021

Pts will continue study treatment (Arm B) for a total of 24 months from initiation of TARE or until intolerable toxicity or disease progression occur, whichever is earlier. Enrollment began in September 2020.

"Contrary to previous reports, these data demonstrate that hepatectomy following Y90 is safe in well-selected populations. This multi-disciplinary treatment paradigm should be more widely studied for patients with inadequate FLR and few other treatment options."