Registry for patients with unresectable liver tumors treated with SIR-Spheres
Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
This study is collecting information on how well SIR-Spheres treatment works for people with liver tumors that can't be removed and who haven't responded to chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 845 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sirtex Medical Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Clichy, Cedex and 8 other locations) |
| Trial ID | NCT05967143 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect extensive data on the use of SIR-Spheres in patients with unresectable hepatocellular carcinoma (HCC) or liver metastases from colorectal cancer (mCRC) who are refractory to or intolerant to chemotherapy. The study will involve approximately 845 patients across 44 sites in 10 countries, assessing real-world clinical responses to SIRT with SIR-Spheres. The goal is to validate the safety and effectiveness of this treatment in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable HCC or liver metastases from mCRC who are suitable for SIR-Spheres treatment.
Not a fit: Patients who have previously received radiation treatment to the liver or are participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of SIR-Spheres for patients with difficult-to-treat liver tumors.
How similar studies have performed: While this approach is observational, similar studies using SIR-Spheres have shown promising results in treating liver tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Confirmed diagnosis of: * Unresectable hepatocellular carcinoma (HCC) Or * Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy * Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice * Planned to receive SIR-Spheres treatment to the liver for the first time * Provision of signed patient informed consent Exclusion Criteria: * Prior radiation treatment to the liver Caveat: Sequential selective internal radiation therapy (SIRT) treatment is allowed * Patients participating in any interventional clinical trial with an investigational product, device, or procedure * Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Where this trial is running
Clichy, Cedex and 8 other locations
- Hôpital Beaujon — Clichy, Cedex, France (Recruiting)
- Hopital Henri Mondor — Créteil, Paris, France (Not_yet_recruiting)
- Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud — Pierre-Bénite, Rhône, France (Recruiting)
- Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañon — Madrid, Spain (Not_yet_recruiting)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (Not_yet_recruiting)
- The Christie Hospital — Manchester, Lancashire, United Kingdom (Not_yet_recruiting)
- Kings College Hospital — London, United Kingdom (Not_yet_recruiting)
- Hammersmith Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Janet Bell
- Email: jbell@sirtex.com
- Phone: 781-721-3840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.