Unresectable Hepatocellular Carcinoma (HCC)SIRtainNCT05967143
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
An observational study of Unresectable Hepatocellular Carcinoma (HCC) and Liver Metastases From Colorectal Cancer (mCRC), run by Sirtex Medical at 9 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC)
- What is being tested?
- SIRT
- Type of treatment
- Medical device
- How many people
- 845 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 19 Jun 2023to Jun 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
France3 sites, 3 recruiting
- Recruiting
Hôpital Beaujon
Clichy, Cedex, 92118
Mohamed Bouattour
- Not yet recruiting
Hopital Henri Mondor
Créteil, Paris, 94000
Hélène Regnault
- Recruiting
Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
Pierre-Bénite, Rhône, 69495
Nicolas Jacquet-Francillon
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Pilar Garcia Alfonso
- Not yet recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28220
Lourdes Gutierrez
- Not yet recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Paloma Lluch
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Kings College Hospital
London, SE5 9RS
Paul Ross
- Not yet recruiting
Hammersmith Hospital
London, W12 OHS
Rohini Sharma
- Not yet recruiting
The Christie Hospital
Manchester, Lancashire, M20 4BX
Saifee Mullamitha
About this study
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)
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
Read the 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.
- Conditions
- Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC)
- Being tested
- SIRT
- Keywords
- Liver metastases from colorectal cancer (mCRC), Unresectable Hepatocellular carcinoma (HCC), SIR-Spheres microspheres, Y-90 resin microspheres, SIRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRTDevice
Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
| Study group | Role | What they receive |
|---|---|---|
| Patients with unresectable HCC or unresectable liver metastases from mCRC | 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. Receives: Device: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 24months from LPI
Liver PFS (LPFS)
Measured: 24months from LPI
Overall survival (OS)
Measured: 24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
Measured: 24months from LPI
Duration of response (DoR)
Measured: 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.
Measured: 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.
Measured: 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').
Measured: 24months from LPI
Secondary outcomes (3)
SAEs/SADE's rates
Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
Measured: 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
Measured: 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.
Measured: 24months from LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start19 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 845 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sirtex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967143
- Sponsor's protocol ID
- STX2501
- Acronym
- SIRtain
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05967143
- Acronym / sponsor ID
- SIRtain / STX2501
- Conditions
- Unresectable Hepatocellular Carcinoma (HCC), Liver Metastases From Colorectal Cancer (mCRC)
- Keywords
- Liver metastases from colorectal cancer (mCRC), Unresectable Hepatocellular carcinoma (HCC), SIR-Spheres microspheres, Y-90 resin microspheres, SIRT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- Sirtex MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unresectable HCC or unresectable liver metastases from mCRC | – | Device: SIRTThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Prior radiation treatment to the liver
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRTSelective internal radiation therapy with SIR-Spheres Y90 resin microspheres. | Device | Patients with unresectable HCC or unresectable liver metastases from mCRC |
Primary outcome
Progression-free survival (PFS)
Time frame: 24months from LPI
Liver PFS (LPFS)
Time frame: 24months from LPI
Overall survival (OS)
Time frame: 24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
Time frame: 24months from LPI
Duration of response (DoR)
Time frame: 24months from LPI
Change scores from baseline to follow-up timepoints of the EQ-5D-5L
Time frame: 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)
Time frame: 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)
Time frame: 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').
3 secondary outcomes
SAEs/SADE's rates
Time frame: 24months from LPI
Subsequent hepatic procedures summarized at follow-up timepoints
Time frame: 24months from LPI
Healthcare Resource Utilization summarized at follow-up timepoints
Time frame: 24months from LPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinoma (HCC) and Liver Metastases From Colorectal Cancer (mCRC), run by Sirtex Medical at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Bell (781-721-3840, jbell@sirtex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 24months from LPI). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.