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Recruiting NCT05967143

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

— Observational Unresectable Hepatocellular Carcinoma (HCC) Liver Metastases From Colorectal Cancer (mCRC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIRT.
Who it may be relevant to
Registry conditions: Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)

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

Detailed 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.

Interventions

  • Device SIRT
    Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: 24months from LPI]
  • Liver PFS (LPFS) [Time frame: 24months from LPI]
  • Overall survival (OS) [Time frame: 24months from LPI]
  • Objective response rate (ORR) and liver response rate (LRR) [Time frame: 24months from LPI]
  • Duration of response (DoR) [Time frame: 24months from LPI]
  • Change scores from baseline to follow-up timepoints of the EQ-5D-5L [Time frame: 24months from LPI]
  • Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) [Time frame: 24months from LPI]
  • Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18) [Time frame: 24months from LPI]
Secondary outcome measures (3)
  • SAEs/SADE's rates [Time frame: 24months from LPI]
  • Subsequent hepatic procedures summarized at follow-up timepoints [Time frame: 24months from LPI]
  • Healthcare Resource Utilization summarized at follow-up timepoints [Time frame: 24months from LPI]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Hôpital Beaujon — Clichy
  • Hopital Henri Mondor — Créteil
  • Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud — Pierre-Bénite
Spain · 3 centers
  • Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda
  • Hospital General Universitario Gregorio Marañon — Madrid
  • Hospital Clinico Universitario de Valencia — Valencia
United Kingdom · 3 centers
  • The Christie Hospital — Manchester
  • Kings College Hospital — London
  • Hammersmith Hospital — London

Identifiers

NCT: NCT05967143 · STX2501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗