RecruitingNot Applicable

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

France, Spain, United Kingdom845 participantsStarted 2023-06-19

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival (PFS)

Timeframe: 24months from LPI

Liver PFS (LPFS)

Timeframe: 24months from LPI

Overall survival (OS)

Timeframe: 24months from LPI

Objective response rate (ORR) and liver response rate (LRR)

Timeframe: 24months from LPI

Duration of response (DoR)

Timeframe: 24months from LPI

Change scores from baseline to follow-up timepoints of the EQ-5D-5L

Timeframe: 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)

Timeframe: 24months from LPI

Trial details

NCT IDNCT05967143

SponsorSirtex Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06

Contact for this trial

Janet Bell

781-721-3840 jbell@sirtex.com

View on ClinicalTrials.gov More Unresectable Hepatocellular Carcinoma (HCC) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Progression-free survival (PFS)

Timeframe: 24months from LPI

Liver PFS (LPFS)

Timeframe: 24months from LPI

Overall survival (OS)

Timeframe: 24months from LPI

Objective response rate (ORR) and liver response rate (LRR)

Timeframe: 24months from LPI

Duration of response (DoR)

Timeframe: 24months from LPI

Change scores from baseline to follow-up timepoints of the EQ-5D-5L

Timeframe: 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)

Timeframe: 24months from LPI