Liver, Cancer of, Non-ResectableHope166NCT03563274
QuiremSpheres Observational Study
An observational study of Liver, Cancer of, Non-Resectable, run by Terumo Europe N.V. at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver, Cancer of, Non-Resectable
- What is being tested?
- Selective Internal Radiation Therapy with QuiremSpheres®
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jun 2018to 31 Jul 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with unresectable primary liver cancer or unresectable metastases in the liver.
Who may be able to join
- Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
- Patient is ≥ 18 years
- Patient has understood and signed written informed consent to data collection in the study
Who cannot join
- Patient's refusal
- Local practice guidelines prohibiting the patient to receive SIRT
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Observational, Multicenter Study to Further Confirm The Efficacy and Safety of QuiremSpheres® (Holmium-166 Microspheres) Selective Internal Radiation Therapy (SIRT) in Unresectable Liver Cancer Patients.
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
Read the detailed description
Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).
- Conditions
- Liver, Cancer of, Non-Resectable
- Being tested
- Selective Internal Radiation Therapy with QuiremSpheres®
- Keywords
- Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Internal Radiation Therapy with QuiremSpheres®Device
Also called SIRT, Radioembolization
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
- Tumor response in the liver
- Tumor response in liver for overall population and each tumor type, assessed 3 months after SIRT has been completed as per routine practice following the corresponding guidelines for each tumor type (e.g. RECIST, mRECIST, EASL)
Measured: 3 months
Safety
- Frequency and Severity of Adverse Events
- Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) and all adverse device effects (ADE) occurring during and after treatment throughout follow up of patients. Severity of adverse events will be rated following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety assessment will also be based on routine blood tests with an emphasis on the liver function parameters obtained at baseline, after the SIRT procedure and throughout the follow up period.
Measured: 12 months
Secondary outcomes (4)
Time to progression in liver and overall
Time from SIRT procedure until progression in liver / overall progression
Measured: 12 months
Progression free survival in liver and overall
Time from SIRT procedure until progression in liver / overall progression or death.
Measured: 12 months
Overall survival rate
Time from SIRT procedure until death from any cause
Measured: 12 months
Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…)
Number of patients that after the SIRT procedure underwent a surgery or transplantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start21 Jun 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: did not meet planned recruitment expectations with a slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver, Cancer of, Non-ResectableStudies 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
- 20 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dragica Paunovic, MD, Study director, Chief Medical Officer at Terumo Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563274
- Sponsor's protocol ID
- T131E1
- Acronym
- Hope166
- Status last verified
- Mar 2021
- First submitted
- 8 Jun 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Multicenter Study to Further Confirm The Efficacy and Safety of QuiremSpheres® (Holmium-166 Microspheres) Selective Internal Radiation Therapy (SIRT) in Unresectable Liver Cancer Patients.
- ClinicalTrials.gov ID
- NCT03563274
- Acronym / sponsor ID
- Hope166 / T131E1
- Conditions
- Liver, Cancer of, Non-Resectable
- Keywords
- Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: did not meet planned recruitment expectations with a slow recruitment rate
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 20 Jun 2018 (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.
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
Detailed description
Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable primary liver cancer or unresectable metastases in the liver.
Key inclusion criteria (3 listed)
- Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
- Patient is ≥ 18 years
- Patient has understood and signed written informed consent to data collection in the study
Key exclusion criteria (2 listed)
- Patient's refusal
- Local practice guidelines prohibiting the patient to receive SIRT
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 |
|---|---|---|
| Selective Internal Radiation Therapy with QuiremSpheres®Also: SIRT, RadioembolizationThe main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board. | Device | – |
Primary outcome
Tumor response
Time frame: 3 months
1. Tumor response in the liver • Tumor response in liver for overall population and each tumor type, assessed 3 months after SIRT has been completed as per routine practice following the corresponding guidelines for each tumor type (e.g. RECIST, mRECIST, EASL)
Safety
Time frame: 12 months
2. Frequency and Severity of Adverse Events • Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) and all adverse device effects (ADE) occurring during and after treatment throughout follow up of patients. Severity of adverse events will be rated following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety assessment will also be based on routine blood tests with an emphasis on the liver function parameters obtained at baseline, after the SIRT procedure and throughout the follow up period.
4 secondary outcomes
Time to progression in liver and overall
Time frame: 12 months
Progression free survival in liver and overall
Time frame: 12 months
Overall survival rate
Time frame: 12 months
Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: did not meet planned recruitment expectations with a slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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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. This study is not recruiting at the moment.
Dragica Paunovic, MD study director
Chief Medical Officer at Terumo Europe
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver, Cancer of, Non-Resectable, run by Terumo Europe N.V. at 2 sites in 2 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
The study was stopped early (reason given: did not meet planned recruitment expectations with a slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 3 months). The study lists 2 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 29 Mar 2021.