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

Recruiting

• Conditions: Unresectable Hepatocellular Carcinoma (HCC); Liver Metastases From Colorectal Cancer (mCRC)
• Interventions: Device: SIRT

• Registration Number: NCT05967143
• Lead Sponsor: Sirtex Medical

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

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.

Study Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2028-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 845

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with unresectable HCC or unresectable liver metastases from mCRC	SIRT	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.

Primary Outcome Measures

Name	Time	Method
Liver PFS (LPFS)	24months from LPI
Progression-free survival (PFS)	24months from LPI
Objective response rate (ORR) and liver response rate (LRR)	24months from LPI
Overall survival (OS)	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').

Secondary Outcome Measures

Name	Time	Method
Healthcare Resource Utilization summarized at follow-up timepoints	24months from LPI	The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.
SAEs/SADE's rates	24months from LPI	Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
Subsequent hepatic procedures summarized at follow-up timepoints	24months from LPI	Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints

Trial Locations

Locations (9)

Hôpital Beaujon; 🇫🇷 Clichy, Cedex, France

Hospital Universitario Puerta de Hierro - Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Hopital Henri Mondor; 🇫🇷 Créteil, Paris, France

Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, Rhône, France

The Christie Hospital; 🇬🇧 Manchester, Lancashire, United Kingdom