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

PRECISE: Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Olivia Newton-John Cancer Research Institute

New P1 trial • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

A Study Evaluating the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres to Bridge or Downstage Patients With Hepatocellular Carcinoma (HCC) to Liver Transplant or Resection and Elicit Pathologic Necrosis. (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Sirtex Medical

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor • Transplantation

Aspartate Aminotransferase to Platelet Index (APRI) as a Prognostic Factor for Overall Survival After TARE Y90 Resin Microspheres in Primary Liver Cancer Patients: Results from the European, Prospective Observational Study CIRT. (PubMed, Cardiovasc Intervent Radiol) - P | "APRI may be a promising, easily accessible prognostic biomarker for OS after TARE in ICC and HCC patients. Its prognostic value may be influenced by tumour type and counteracted by dosimetry method, supporting further investigation on this topic. Trial registration NCT02305459."

Biomarker • Journal • Observational data • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

DOORwaY90: Selective Internal Radiation Therapy using SIR-Spheres Y-90 Resin Microspheres as first-line treatment for unresectable Hepatocellular Carcinoma patients (NCT04736121) – an interim analysis (SNMMI 2026) - P=N/A | "Interim analysis of DOORwaY90 data demonstrated a positive study with favorable safety and efficacy that led to FDA-approval of 90Y-resin microspheres for the treatment of unresectable HCC using partition dosimetry. The final results will have matured and be available by the time of the presentation."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Radiation injury to the lung caused by yttrium-90 resin microspheres (SIR-Spheres) diagnosed by transbronchial lung biopsy. (PubMed, Am J Clin Pathol) - "This is the first report of a case in which transbronchial lung biopsy led to diagnosis of 90Y-related radiation lung injury in a patient in whom this diagnosis was not previously suspected clinically or radiologically. We recommend adding 90Y to the list of etiologies of acute lung injury with eosinophils. Pathologists should familiarize themselves with the histologic appearance of 90Y microspheres because identification of these structures in the lung can be diagnostic."

Journal • Acute Lung Injury • Gastrointestinal Disorder • Hepatocellular Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Respiratory Diseases • Solid Tumor

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial primary completion date: Feb 2026 ➔ Feb 2027 | Trial completion date: Feb 2026 ➔ Feb 2027

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

DOORwaY90: Selective Internal Radiation Therapy using SIR-Spheres Y-90 Resin Microspheres as First-Line Treatment for Unresectable Hepatocellular Carcinoma Patients (NCT04736121) – An Interim Analysis (HCC-LIVE 2026) - P=N/A | No abstract available

Clinical • Hepatocellular 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 | Recruiting | Sponsor: City of Hope Medical Center | Initiation date: Dec 2025 ➔ Apr 2026

IO biomarker • Trial initiation date • Breast Cancer • Oncology • Solid Tumor • CD4 • PD-L1

Feasibility of Radioembolization With Yttrium-90 Resin Microspheres Without Lung Shunt Fraction Measurement for Intrahepatic Cholangiocarcinoma. (PubMed, Korean J Radiol) - "Streamlined radioembolization without LSF assessment appears feasible and may represent a practical alternative to conventional multi-step workflows in patients with ICC measuring less than 10 cm."

Journal • Biliary Cancer • Cholangiocarcinoma • Oncology • Pneumonia • 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 | Active, not recruiting | Sponsor: Sirtex Medical | Trial completion date: Dec 2026 ➔ Sep 2026

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Thomas Jefferson University | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Dec 2024

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

MAA-Based Dosimetry for Predicting Tumor Response and Survival Post-TARE in Liver Metastasis Patients (EANM 2025) - "Materials and Methods Population : 145 TARE therapies (SIR-Spheres, Sirtex Medical Europe GmbH, Bonn, Germany) in liver metastasis patients...Results Responders received a significantly higher mean tumor dose (Dmean) (177.2 Gy ± 54.6) compared to non-responders (139.6 Gy ± 48.1; p<0.05). Median OS was 34.6 months for responders vs. 13.5 months for non-responders ( p=0.0175 ) ROC analysis proposed a Dmean cutoff of 122.8 Gy (sensitivity: 0.96, specificity: 0.39) However , patient stratification by this cutoff did not yield a significant OS difference (p=0.173) Conclusion Responders (15%) exhibited both higher Dmean and prolonged OS compared to non-responders A Dmean cutoff of 122.8 Gy was identified as a potential predictor of therapy response, but failed to significantly differentiate OS in this cohort..."

Clinical • Oncology

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=100 | Recruiting | Sponsor: National Cancer Centre, Singapore | N=176 ➔ 100 | Trial completion date: Oct 2026 ➔ Jan 2028 | Trial primary completion date: Apr 2025 ➔ Jul 2026

Enrollment change • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor • CD4

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (clinicaltrials.gov) - P=N/A | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P1 ➔ P=N/A

Phase classification • Liver Cancer • Oncology • Solid Tumor

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: City of Hope Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Tumor mutational burden • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • PD-L1

NEW INDICATION OF THE GROUP’S GLOBALLY INNOVATIVE RADIOACTIVE PRODUCT SIR-SPHERES Y-90 RESIN MICROSPHERE INJECTION IS OFFICIALLY APPROVED IN EUROPE (HKEXnews) - "The approval of the new indications expands the scope of application of this therapy from unresectable hepatocellular carcinoma ('HCC') and unresectable metastatic liver tumors from primary colorectal cancer ('mCRC') to multiple indications, including unresectable intrahepatic cholangiocarcinoma ('ICC'), hepatic metastases by neuroendocrine tumors ('mNET'), or other liver metastases, covering a more comprehensive classification of primary liver cancer and secondary liver metastasis."

EMA approval • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Neuroendocrine Tumor • Hepatocellular Cancer

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

Enrollment open • IO biomarker • Breast Cancer • Oncology • Solid Tumor • PD-L1

Sirtex Medical’s SIR-Spheres Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma (PRNewswire) - "Sirtex Medical...announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S...This regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres in treating HCC."

FDA approval • Hepatocellular Cancer

Dosimetry in safety assessment of elevated pulmonary doses from radionuclide therapies (SNMMI 2025) - " Retrospective review of the dosimetric analysis and follow up of four patients who underwent therapy with [177Lu] Lu-PSMA-617, [177Lu] Lu-DOTATATE, [131I] NaI, and [90Y] SIR-Spheres® was done. 1. A 73-year-old-male with a history of papillary thyroid cancer treated with thyroidectomy and [131I] NaI therapy 19 years ago (therapeutic activity currently unknown) presented with diffuse iodine avid metastases to the lungs underwent pretreatment imaging and dosimetry with [131I] NaI. Lung uptake was measured to be 45% at 48 hours post-administration."

Clinical • Castration-Resistant Prostate Cancer • Endocrine Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Pulmonary Disease • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Budget Impact of Shifting the Treatment Setting of Unresectable Liver Metastases Associated with Primary Colorectal Cancer Using Y-90 Resin Microspheres from the Outpatient Hospital to the Office-Based Laboratory. (PubMed, Clinicoecon Outcomes Res) - "In sensitivity analyses, annual cost savings for the health plan were affected by both the proportion of patients shifted and the setting they were shifted into. Shifting a percentage of the treatment of unresectable liver metastases with Y-90 SIRT to the OBL setting results in modest cost benefits for US health plans."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor

SIRCCA: SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2/3 | N=89 | Terminated | Sponsor: Sirtex Medical | Completed ➔ Terminated; Slow enrollment

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

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