Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

Recruiting now

Conditions studied: Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC)

In brief

This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

Key facts

Study ID

NCT05967143

Run by

Sirtex Medical

People needed

845

Starts

2023-06-19

Expected to finish

2029-06-01

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud — Pierre-Bénite, Rhône, France (enrolling)
• Hôpital Beaujon — Clichy, Cedex, France (enrolling)
• Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain
• Hospital General Universitario Gregorio Marañon — Madrid, Spain
• Hospital Clinico Universitario de Valencia — Valencia, Spain
• The Christie Hospital — Manchester, Lancashire, United Kingdom
• Kings College Hospital — London, United Kingdom
• Hammersmith Hospital — London, United Kingdom
• Hopital Henri Mondor — Créteil, Paris, France

Full record on ClinicalTrials.gov

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