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SIR-Sphere
SIR-Sphere delivers yttrium-90 radiation directly to liver tumors via microspheres injected into the hepatic artery.
SIR-Sphere delivers yttrium-90 radiation directly to liver tumors via microspheres injected into the hepatic artery. Used for Hepatocellular carcinoma, Liver metastases.
At a glance
| Generic name | SIR-Sphere |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Radioembolization agent |
| Target | Yttrium-90 (Y-90) beta emitter |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SIR-Sphere consists of biocompatible resin microspheres loaded with yttrium-90, a beta-emitting radioisotope. When injected into the hepatic artery, the microspheres lodge in the tumor vasculature and deliver localized radiation therapy to hepatocellular carcinoma and liver metastases while minimizing systemic exposure.
Approved indications
- Hepatocellular carcinoma
- Liver metastases
Common side effects
- Abdominal pain
- Nausea
- Fatigue
- Radiation-induced liver disease
- Elevated liver enzymes
Key clinical trials
- Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres
- Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer (PHASE1)
- CIRSE Registry for SIR-Spheres in France (CIRT-FR)
- Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (NA)
- Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer (PHASE2)
- Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH) (PHASE2, PHASE3)
- SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver (PHASE2)
- 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 (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SIR-Sphere CI brief — competitive landscape report
- SIR-Sphere updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI