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

Unresectable Hepatocellular Carcinoma (HCC) Clinical Trial

— SIRtain  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967143
• Other study ID #: STX2501
• Status: Recruiting
• Start date: June 19, 2023
• Est. completion date: June 2029

Study information

• Verified date: June 2023
• Source: Sirtex Medical
• Contact: Janet Bell
• Phone: 781-721-3840
• Email: jbell[@]sirtex.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 845
• Est. completion date: June 2029
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colorectal Neoplasms
• Neoplasm Metastasis
• Unresectable Hepatocellular Carcinoma (HCC)

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy	Cedex
France	Hopital Henri Mondor	Créteil	Paris
France	Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud	Pierre-Bénite	Rhône
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	Hammersmith Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	The Christie Hospital	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Sirtex Medical

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		24months from LPI
Primary	Liver PFS (LPFS)		24months from LPI
Primary	Overall survival (OS)		24months from LPI
Primary	Objective response rate (ORR) and liver response rate (LRR)		24months from LPI
Primary	Duration of response (DoR)		24months from LPI
Primary	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
Primary	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
Primary	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	SAEs/SADE's rates	Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates	24months from LPI
Secondary	Subsequent hepatic procedures summarized at follow-up timepoints	Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints	24months from LPI
Secondary	Healthcare Resource Utilization summarized at follow-up timepoints	The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.	24months from LPI