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

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 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

This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision.

The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.

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.