Overview
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
Description
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.
Eligibility
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.