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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: SIRT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with unresectable HCC or unresectable liver metastases from mCRC<br>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<br>* Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs/SADE's rates | Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates | 24months from LPI | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver metastases from colorectal cancer (mCRC), Unresectable Hepatocellular carcinoma (HCC), SIR-Spheres microspheres, Y-90 resin microspheres, SIRT