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Clinical Trials in Spain / NCT05967143
Recruiting Observational

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

NCT05967143 · tracked via the Priya Life Science Spain tracker
Sponsor
Sirtex Medical
Phase
Observational
Started
2023-06-19
Last updated
2024-11-27

Condition(s) studied

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

Investigational drug(s) / intervention(s)

SIRT

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-free survival (PFS) — 24months from LPI
  • Liver PFS (LPFS) — 24months from LPI
  • Overall survival (OS) — 24months from LPI
  • Objective response rate (ORR) and liver response rate (LRR) — 24months from LPI
  • Duration of response (DoR) — 24months from LPI
  • Change scores from baseline to follow-up timepoints of the EQ-5D-5L — 24months from LPI
    The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.
  • 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) — 24months from LPI
    The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.
  • 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) — 24months from LPI
    The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').

Trial sites (9)

FacilityCityRegionStatus
Hôpital Beaujon Clichy Cedex Recruiting
Hopital Henri Mondor Créteil Paris Not Yet Recruiting
Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud Pierre-Bénite Rhône Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid Not Yet Recruiting
Hospital General Universitario Gregorio Marañon Madrid Spain Not Yet Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Not Yet Recruiting
The Christie Hospital Manchester Lancashire Not Yet Recruiting
Kings College Hospital London United Kingdom Not Yet Recruiting
Hammersmith Hospital London United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05967143 on ClinicalTrials.gov ↗ ← All trials in Spain