Registry for patients with unresectable liver tumors treated with SIR-Spheres

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Beaujon
  Clichy, Cedex, France Recruiting
• Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
  Pierre-Bénite, Rhône, France Recruiting
• Hopital Henri Mondor
  Créteil, Paris, France Not yet 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

Study contacts

• Study coordinator: Janet Bell
• Email: jbell@sirtex.com
• Phone: 781-721-3840

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.