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

Last updated: November 26, 2024
Sponsor: Sirtex Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

SIRT

Clinical Study ID

NCT05967143
STX2501
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Confirmed diagnosis of:

  • Unresectable hepatocellular carcinoma (HCC) Or

  • Unresectable liver metastases from colorectal cancer (mCRC) refractory to orintolerant to chemotherapy

  • Identified as a candidate for SIR-Spheres treatment as deemed appropriate during thenormal course of practice

  • Planned to receive SIR-Spheres treatment to the liver for the first time

  • Provision of signed patient informed consent

Exclusion

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 investigationalproduct, device, or procedure

  • Need for surrogate consent. Patients who are not able to consent on behalf ofthemselves are not eligible.

Study Design

Total Participants: 845
Treatment Group(s): 1
Primary Treatment: SIRT
Phase:
Study Start date:
June 19, 2023
Estimated Completion Date:
June 30, 2029

Study 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.

Connect with a study center

  • Hôpital Beaujon

    Clichy, Cedex 92118
    France

    Active - Recruiting

  • Hopital Henri Mondor

    Créteil, Paris 94000
    France

    Site Not Available

  • Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Rhône 69495
    France

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid 28220
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • The Christie Hospital

    Manchester, Lancashire M20 4BX
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 OHS
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

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