At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SIRT (device)
- How long the study runs
- Study runs about 72 months (dates as stated)
- About the drug or intervention
- SIRT — device: Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study (the SIRtain Registry) is looking at people with liver tumours that cannot be removed by surgery. It includes two groups: people with a type of liver cancer called hepatocellular carcinoma (HCC), and people whose bowel cancer (colorectal cancer) has spread to the liver (called metastases, or mCRC). The study looks at a treatment called SIR-Spheres, which is a type of internal radiation therapy delivered to the liver. It is run by Sirtex Medical, the company that makes the treatment.
Who can take part
- Age 18 or older
- A confirmed diagnosis of either liver cancer (hepatocellular carcinoma, HCC) that cannot be removed by surgery, or bowel cancer that has spread to the liver and chemotherapy has stopped working or could not be tolerated
- Your doctor has decided SIR-Spheres treatment is suitable for you as part of your normal care
- You are planned to receive SIR-Spheres treatment to the liver for the first time
- You sign a consent form to take part
Who may not be able to
- You have had radiation treatment to the liver before (though repeat SIRT treatment given in stages is allowed)
- You are taking part in another clinical trial of an investigational product, device or procedure
- You are unable to give your own consent (someone else cannot consent on your behalf)
What taking part involves
- • Receiving SIR-Spheres treatment, a type of selective internal radiation therapy (SIRT) given to the liver
- • This is an observational study, which means researchers collect information about your normal care — details of any extra tests or assessments are not stated — ask the trial team
Time commitment: Number of visits, how long the study lasts, and what taking part involves are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 845
- Started
- 2023-06-19
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for unresectable hepatocellular carcinoma (hcc)
- • Clinical study - 845 participants
- • 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 take part?
- • Ages 18 Years and over
- • Diagnosed with unresectable hepatocellular carcinoma (hcc)
Where?
- • Manchester - The Christie Hospital
- • London - Kings College Hospital
- • London - Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 drug treatment
- ✓Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
Who cannot take part
- ✗Prior radiation treatment to the liver
- ✗Caveat:
- ✗Sequential selective internal radiotherapy (SIRT) treatment is allowed
- ✗Patients participating in any interventional clinical trial with an the the study treatment, device, or procedure
- ✗Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
See the full criteria
Where Is This Study? (3 UK sites)
The Christie Hospital
Manchester M20 4BX, United Kingdom
Kings College Hospital
London SE5 9RS, United Kingdom
Hammersmith Hospital
London W12 OHS, United Kingdom
How to Get in Touch
Janet Bell
Sponsor contactCONTACT