Testing Embolization for colorectal cancer liver metastases (CRLM)
Official title: The DRAGON 2 Trial
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)
- 2 groups
- Sites in Montreal, Vancouver and 3 more cities
- Recruiting
Interventions
- Medical procedure
Embolization
Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Canadian Sites (5)
4 of 5 recruiting
- Recruiting
Vancouver Coastal Health
Vancouver, British Columbia
- Recruiting
Juravinski Hospital and Cancer Centre
Hamilton, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Sunnybrook Hospital
Toronto, Ontario
- Not yet recruiting
McGill University Health Center
Montreal
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)
- +Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.
- +18 Years and older
- +Men and women
- +Able to understand the trial and provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
Exclusion
- −Patients with prohibitive comorbidities, decision made by local team
- −Any patient with non-resectable or non-ablatable extrahepatic disease
- −Patients with hepatic malignancies other than CRLM
- −Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
- −The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
- −Pregnant or lactating female.
- −Premenopausal females not able or willing to commit to oral contraception
- −Progression of disease by RECIST criteria after cytoreduction chemotherapy
- −Complete response after conversion chemotherapy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Embolization.
Registry label: A: Portal Vein Embolization (PVE) alone - (control arm)
Group B receives Embolization.
Registry label: B: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 348 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: 3 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Volume sufficient for resection at week 3 after the embolization — measured over 3 weeks.
5-year Overall Survival — measured over 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05428735 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About EmbolizationProcedure
Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 weeks.
The study as a whole is currently expected to finish around 2029-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 348 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Montreal, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
Someone at Concord will read your request and email you. The study team decides who takes part.
Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.