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

Sirtex Medical

Status: Enrolling

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

Treatments: Device: SIRT

Study type: Observational

Funder types: Industry

Identifiers

NCT05967143

STX2501

Details and patient eligibility

About

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

Full 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.

Enrollment: 845 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

845 participants in 1 patient group

Patients with unresectable HCC or unresectable liver metastases from mCRC

Description:

This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.

Treatment:

Device: SIRT