SIR-Spheres (yttrium-90 microspheres) / SIRTeX Medical - LARVOL DELTA

Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial. (PubMed, J Patient Rep Outcomes) - P2 | "Combining SIRT with nivolumab did not compromise HRQoL in patients with unresectable HCC. Study results were limited by the small number of patients but, combined with the previously reported clinical outcomes, suggested that the treatment combination deserves further consideration in this difficult-to-treat population."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2025 ➔ Jan 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Hepatology • Liver Cancer • Oncology • Solid Tumor

Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=11 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Breast Cancer • Hepatology • Oncology • Solid Tumor

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

IO biomarker • Trial completion date • Trial primary completion date • Tumor mutational burden • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • PD-L1 • TMB

Safety and Efficacy of Selective Internal Radiation Therapy for Portal Vein Tumour Thrombus in Advanced Hepatocellular Carcinoma: A Single-Centre Experience in Australia. (PubMed, J Med Imaging Radiat Oncol) - "Our cohort suggests that SIRT is a safe and effective treatment option for a difficult-to-treat patient population. Our data suggest a longer OS for those with preserved liver function, good functional status and low AFP levels at 21.2 months. Poor pre-treatment liver function and functional status are predictors of decompensation, and decompensation is a predictor of poor survival. These data provide an Australasian perspective and support the expanding role of SIRT in HCC treatment guidelines. Further prospective studies with larger sample sizes and longer follow-up are warranted to confirm these findings."

Journal • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Solid Tumor • Thrombosis

Dosimetry Assessment in Predicting Treatment Outcomes Following Yttrium-90 Transarterial Radioembolization of Hepatic Tumors. (PubMed, Cancer Biother Radiopharm) - "Purpose: To evaluate the use of yttrium-90 (Y90) dosimetry in predicting treatment outcomes when used following transarterial radioembolization with SIR-Spheres® (Resin Y90) in patients with hepatic tumors...Time to death and mean dose to nontumor was associated in hepatocellular carcinoma patients (p = 0.0421), but not the colorectal carcinoma or other subgroup. Voxel-based dosimetry assessment is a tool that may be utilized to assist in predicting treatment outcomes in responders to transarterial radioembolization."

Journal • Colorectal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

SirTac: Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis (clinicaltrials.gov) - P2 | N=108 | Completed | Sponsor: Charite University, Berlin, Germany | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Jul 2022 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study. (PubMed, Cardiovasc Intervent Radiol) - "In our cohorts, patients performed similarly regarding clinical outcomes irrespective of their analysis group based on reimbursement recommendations. Our results suggest that instead of restrictive reimbursement criteria, more decision-making power in selecting suitable patient groups could be given to multidisciplinary tumour boards. Results confirm that TARE with Y90 resin microspheres is an effective and safe treatment for liver cancer, with maintained HRQoL in most patients."

Journal • Observational data • Reimbursement • US reimbursement • Colorectal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: GrandPharma (China) Co., Ltd.

New trial • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Initial Outcomes of Integrating Yttrium-90 Radioembolization with Capecitabine-Temozolomide for Grade 3 Liver-Dominant Metastatic Neuroendocrine Tumors (NANETS 2024) - "Resin Y90 microspheres (SIR-Spheres) were administered using the body surface area method. CONCLUSIONS Integrated CapTemY90 chemotherapy and radioembolization showed acceptable toxicity, not greater than expected in this cohort of patients with G3 NETs. Hepatic and overall PFS suggest improved outcomes compared to that reported in the literature for G3 NETs treated with standard embolotherapy, noting that ours is a small cohort."

Metastases • Anemia • Endocrine Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thrombocytopenia

Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres (clinicaltrials.gov) - P=N/A | N=1 | Completed | Sponsor: Methodist Health System | Recruiting ➔ Completed | N=300 ➔ 1

Enrollment change • Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor

Cover it all with SIR-Spheres (CIRSE 2024) - "Sponsored by Sirtex"

Hepatocellular Cancer • Oncology

DOORwaY90: Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Sirtex Medical | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Sirtex Medical Launches SIR-Spheres FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans (PRNewswire) - "Sirtex Medical...announced today the launch of its SIR-Spheres FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer....SIR-Spheres FLEXdose SELECT Delivery Program offers unparalleled flexibility by enabling tailored, patient-specific dosing from a single 3mL delivery vial."

Commercial • Colorectal Cancer

90Y SIR-Spheres Activity Measurement with New SIROS D-Vial Delivery Kit. (PubMed, J Nucl Med Technol) - " SIROS D-vial 90Y activity can be accurately and reliably estimated directly using setting 51 × 10 on both the CRC-15R and the CRC-55tR dose calibrators (errors within ±0.5%) and indirectly with an exposure-rate reading at 30 cm using conversion factor 0.664 ± 0.003 GBq/(mR/h) (R 2 = 0.985). Dose calibrator settings and exposure-rate-to-activity conversion factor for 90Y activity assays with new SIROS kit should be updated from legacy V-Vial parameters to avoid an approximately 10% underestimation."

Journal

Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P=N/A | N=6 | Terminated | Sponsor: Medical University of South Carolina | Active, not recruiting ➔ Terminated; Enrollment closed by internal scientific review committee due to slow accrual.

Trial termination • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4

Outcomes Analysis of 90Y Radioembolization for Tumors Other Than Metastatic Colorectal Cancer from the RESiN (Radiation-Emitting SIR-spheres in Non-resectable liver tumors) Registry. (PubMed, J Vasc Interv Radiol) - P=N/A | "Real-world data demonstrate the use of resin 90Y-TARE in m-nonCRC refractory to standard chemotherapy. For some cell types, this expanded use achieved superior treatment outcomes relative to the reference standard of mCRC, suggesting the need for inquiry into broadened indications for 90Y-TARE."

Journal • Metastases • Breast Cancer • Colorectal Cancer • Endocrine Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

DOORwaY90: Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Sirtex Medical | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

In Silico Computational Fluid Dynamics Modeling of Yttrium-90 Microspheres Targeting Liver Tumors (SNMMI 2024) - "We considered one of the most clinically available types of yttrium-90 microsphere, SIR-Spheres® with a diameter of 32 ±10µm and density of 1600 kg/m3... Computational fluid dynamics is employed to model the transient fluid flow and particle hemodynamics in a representative hepatic arterial system during yttrium-90 microsphere radioembolization. The study highlights that adjusting the catheter opening position and time intervals of microsphere injection can guide the microspheres to preferred vessels, minimizing non-target particle delivery. While our study offers valuable insights, further research is needed to assess practical constraints towards seamless clinical translation."

Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

YTTRIUM-90 RADIOEMBOLIZATION FOR INTRAHEPATIC CHOLANGIOCARCINOMA: OUR EXPERIENCE AT A NON UNIVERSITY TERTIARY CARE CENTER (NUTCC) (DDW 2024) - "All patients in this cohort received Sir-spheres Y-90 treatment...Thus reflective of a positive therapeutic response. Nevertheless further research is necessary to validate reliable downsizing of tumor burden through the use of Y-90 with the goal of tumor resection in inoperable ICC."

Biliary Cancer • Cardiovascular • Cholangiocarcinoma • Diabetes • Gastrointestinal Cancer • Hypertension • Metabolic Disorders • Oncology • Palliative care • Solid Tumor

YTTRIUM-90 RADIOEMBOLIZATION FOR INTRAHEPATIC CHOLANGIOCARCINOMA: OUR EXPERIENCE AT A NON UNIVERSITY TERTIARY CARE CENTER (NUTCC) (SSAT 2024) - "All patients in this cohort received Sir-spheres Y-90 treatment...Thus, reflective of a positive therapeutic response. Nevertheless, further research is necessary to validate reliable downsizing of tumor burden through the use of Y-90 with the goal of tumor resection in inoperable ICC."

Biliary Cancer • Cardiovascular • Cholangiocarcinoma • Diabetes • Gastrointestinal Cancer • Hypertension • Metabolic Disorders • Oncology • Palliative care • Solid Tumor • Type 2 Diabetes Mellitus

Feasibility of Liver Transplantation after 90Y Radioembolization: Lessons from a Radiation Protection Incident. (PubMed, Health Phys) - "This dosimetric study suggests the feasibility of shortening the delay for liver transplantation/surgery after radioembolization from the 8th or 15th day after using SIR-Spheres or TheraSphere, respectively. This delay can be decreased further when adjusted to the administrated activity while upholding radiation protection standards for healthcare professionals."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • Transplantation

Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Methodist Health System | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

STRATUM: Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients (clinicaltrials.gov) - P2 | N=176 | Recruiting | Sponsor: National Cancer Centre, Singapore | Trial completion date: Nov 2025 ➔ Oct 2026 | Trial primary completion date: Jan 2024 ➔ Apr 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD4