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

Launched by SIRTEX MEDICAL · Jul 20, 2023

Keywords

ClinConnect Summary

The SIRtain Registry is a clinical trial that is studying the use of a treatment called SIR-Spheres for patients with certain types of liver tumors that cannot be removed with surgery. Specifically, it focuses on patients with unresectable hepatocellular carcinoma (HCC) or liver metastases from colorectal cancer (mCRC), especially those who have not responded to or cannot tolerate chemotherapy. The goal of this study is to collect real-world information about how well SIR-Spheres work and to ensure they are used safely and appropriately in everyday medical practice.

To participate in this study, you must be at least 18 years old and have a confirmed diagnosis of the types of liver tumors mentioned. You should also be considered a suitable candidate for SIR-Spheres treatment and be receiving this treatment for the first time. Participants will need to give their consent to join the study. However, if you have had prior radiation treatment to your liver or are currently involved in another clinical trial with a new treatment, you may not be eligible. This study is currently recruiting participants, and it welcomes individuals of all genders. If you qualify and choose to participate, you will help contribute valuable data that can improve future treatments for liver tumors.

Gender

ALL

Eligibility 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.