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

NCT05967143 | Recruiting FDA Device

• 1 other identifier: STX2501
• Study Type: observational
• Target: 845
• Locations: 3 countries
• Sites: 9

Brief 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

Conditions

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

Keywords

Liver metastases from colorectal cancer (mCRC); Unresectable Hepatocellular carcinoma (HCC); SIR-Spheres microspheres; Y-90 resin microspheres; SIRT

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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)

  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.

  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)

  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').

  24months from LPI

Secondary Outcomes (3)

• SAEs/SADE's rates

  24months from LPI

• Subsequent hepatic procedures summarized at follow-up timepoints

  24months from LPI

• Healthcare Resource Utilization summarized at follow-up timepoints

  24months from LPI

Study Arms (1)

Patients with unresectable HCC or unresectable liver metastases from mCRC

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.

Device: SIRT

Interventions

SIRT DEVICE

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

Patients with unresectable HCC or unresectable liver metastases from mCRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirtex Medical: lead

Study Sites (9)

Hôpital Beaujon

Clichy, Cedex, 92118, France

RECRUITING

Hopital Henri Mondor

Créteil, Paris, 94000, France

NOT YET RECRUITING

Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud

Pierre-Bénite, Rhône, 69495, France

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28220, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

NOT YET RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

NOT YET RECRUITING

The Christie Hospital

Manchester, Lancashire, M20 4BX, United Kingdom

NOT YET RECRUITING

Kings College Hospital

London, SE5 9RS, United Kingdom

NOT YET RECRUITING

Hammersmith Hospital

London, W12 OHS, United Kingdom

NOT YET RECRUITING

Central Study Contacts

Janet Bell

CONTACT

781-721-3840; jbell@sirtex.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

FR (3); ES (3); GB (3)