Metastatic Colorectal CancermCRCNCT04866290
HepaSphere™ Microspheres Prospective Registry
An observational study of Metastatic Colorectal Cancer, run by Merit Medical Systems, Inc. at 2 sites in 2 countries.
Trial summary
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015. The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- HepaSphere Microspheres
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Sep 2016to Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with unresectable metastatic colorectal cancer with metastases to the liver.
Who may be able to join
- Histologically or radiologically confirmed colorectal cancer metastases to the liver
- Patient is able to have either CT or MRI imaging
- Hepatic tumor burden ≥50% of total tumor burden
- Hepatic tumor burden ≤50% of total liver volume
- Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment
- Life expectancy ≥ 3 months
- WHO performance status ≤ 2
Who cannot join
- Previous treatment with any form of hepatic transarterial embolization
- Total bilirubin ≥ 3.0 mg/dL
- Any contraindication for irinotecan administration
- Partial or complete thrombosis of the main portal vein
- Cardiovascular or respiratory failure
- Any other condition deemed exclusionary by the Investigator
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere™ Microspheres Loaded With Irinotecan
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.
The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.
Read the detailed description
This prospective, post-market study was designed to evaluate the median overall survival (MOS) of subjects with metastatic colorectal cancer (mCRC) to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan. This treatment process is referred to as transarterial chemoembolization (TACE).
Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. All study subjects were in one cohort and were not blinded to treatment.
Per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline MRI. Following this baseline visit subjects were to have two TACE cycles (i.e., TACE Cycle 1, TACE Cycle 2), with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1. A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). Following completion of TACE Cycle 1 and TACE Cycle 2, additional TACE cycles could be performed at the investigator's discretion for residual or new disease.
When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles (at the investigator's discretion), they entered follow-up. The study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of TACE Cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- HepaSphere Microspheres
- Keywords
- Colorectal Cancer, Liver metastases, Transarterial chemoembolization
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaSphere MicrospheresDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first
Measured: 24 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Determined by the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) when all subjects enrolled have been followed for survival for 2 years (from date of 1st TACE), are considered lost to follow up, or have died, whichever comes first. Per mRECIST (target lesions assessed by MRI): Complete Response (CR), at least >=30% decrease in the sum of diameters of all viable target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Overall Response (OR) = CR + PR. ORR is calculated as= (no. of patients with CR + the no. of patients with PR) / N. (N= No of participants analyzed)
Measured: 24 months
Best Tumor Response
Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI: Complete Response (CR), at least > =30% decrease in the sum of diameters of all viable ( enhancement in the arterial phase) target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable (enhancement in the arterial phase) target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started.
Best Tumor Response (BTR) was assessed during the period of time between TACE Cycle 1 and the last post-TACE MRI or CT. BTR will be presented as the number of subjects within each response category and percentage of evaluated subjects.
Measured: 24 months
Liver Progression-free Survival
Median liver progression-free survival will be calculated as the time (in months) between the first TACE procedure to the date on which progression of the subject's liver metastases was documented or the date of death (from any cause).
Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI, Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started.
Measured: 24 months
Time to Progression
Time to Progression (TTP) was defined as the length of time between TACE Cycle 1 and disease progression (as determined by MRI or CT imaging) of both hepatic and extrahepatic disease. The date of the first study TACE was time zero.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start22 Sep 2016
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katerina Malagari, MD, Principal investigator, Evgenidio Hospital/ATTIKO Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866290
- Sponsor's protocol ID
- CRC-P4-16-01
- Acronym
- mCRC
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2021
- Last updated
- 3 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere™ Microspheres Loaded With Irinotecan
- ClinicalTrials.gov ID
- NCT04866290
- Acronym / sponsor ID
- mCRC / CRC-P4-16-01
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Liver metastases, Transarterial chemoembolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.
The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.
Detailed description
This prospective, post-market study was designed to evaluate the median overall survival (MOS) of subjects with metastatic colorectal cancer (mCRC) to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan. This treatment process is referred to as transarterial chemoembolization (TACE).
Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. All study subjects were in one cohort and were not blinded to treatment.
Per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline MRI. Following this baseline visit subjects were to have two TACE cycles (i.e., TACE Cycle 1, TACE Cycle 2), with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1. A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). Following completion of TACE Cycle 1 and TACE Cycle 2, additional TACE cycles could be performed at the investigator's discretion for residual or new disease.
When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles (at the investigator's discretion), they entered follow-up. The study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of TACE Cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with unresectable metastatic colorectal cancer with metastases to the liver.
Key inclusion criteria (7 listed)
- Histologically or radiologically confirmed colorectal cancer metastases to the liver
- Patient is able to have either CT or MRI imaging
- Hepatic tumor burden ≥50% of total tumor burden
- Hepatic tumor burden ≤50% of total liver volume
- Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment
Key exclusion criteria (6 listed)
- Previous treatment with any form of hepatic transarterial embolization
- Total bilirubin ≥ 3.0 mg/dL
- Any contraindication for irinotecan administration
- Partial or complete thrombosis of the main portal vein
- Cardiovascular or respiratory failure
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 |
|---|---|---|
| HepaSphere Microspheres | Device | – |
Primary outcome
Overall Survival
Time frame: 24 months
Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
Best Tumor Response
Time frame: 24 months
Liver Progression-free Survival
Time frame: 24 months
Time to Progression
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Katerina Malagari, MD principal investigator
Evgenidio Hospital/ATTIKO Hospital
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 Metastatic Colorectal Cancer, run by Merit Medical Systems, Inc. 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 3 Apr 2023. 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 France, Greece. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: 24 months). 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 3 Apr 2023.