Comparing Portal Vein Embolization with Hepatic Vein Embolization for primary liver cancer
Official title: The Dragon PLC Trial (DRAGON-PLC)
The DRAGON PLC Trial - An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) With PVE Alone in Primary Liver Cancers.
- 2 groups
- Sites in Montreal, Ottawa and 9 more cities
- Recruiting
Interventions
- Medical procedure
Portal Vein Embolization
Description: Portal Vein embolization with Glue by a transhepatic approach
- Medical procedure
Hepatic Vein Embolization
Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Canadian Sites (14)
14 listed, none recruiting
- Not yet recruiting
Foothills Medical Center
Calgary, Alberta
- Not yet recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Not yet recruiting
Centre Hospitalier de l'Université de Montréal
Montreal
- Not yet recruiting
McGill University Health Centre, Montreal
Montreal
- Not yet recruiting
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia
- Not yet recruiting
Juravinski Hospital and Cancer Centre
Hamilton, Ontario
- Not yet recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Not yet recruiting
London Health Sciences Centre
London, Ontario
- Not yet recruiting
St. Joseph's Health Centre
Toronto, Ontario
- Not yet recruiting
Sunnybrook Hospital
Toronto, Ontario
- Not yet recruiting
University Health Network/TGH
Toronto, Ontario
- Not yet recruiting
L'Hopital d'Ottawa
Ottawa
- Not yet recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
- Not yet recruiting
Royal University Hospital
Saskatoon
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years;
- +PLC diagnosis, specifically iCCC, pCCC, and HCC;
- +Requiring PVE due to an FLR volume is \<30% in normally functioning livers, \<40% in livers with potentially impaired function e.g. resulting from prior systemic therapy induction or bile duct colonization / transpapillary biliary drainage, or \<50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR function on hepatobiliary scintigraphy (HEBIS) is \< 2.7 %/min/m2;
- +Able to understand the trial and provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Liver cirrhosis with a Child-Pugh score of B or C;
- −Presence of portal hypertension;
- −Presence of cholangitis;
- −Patients unresectable due to prohibitive comorbidities (decision made by local multidisciplinary team);
- −Patients with hepatic malignancies other than iCCC, pCCC or HCC;
- −PVE/HVE anatomically not feasible;
- −Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.
- −Unable to understand the study information, study instructions and give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Pregnant women;
- −Premenopausal females not able/willing to commit to contraception (specifically long-acting reversible contraception or hormonal contraception);
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 Portal Vein Embolization.
Registry label: A: Portal Vein Embolization (PVE) - control arm
Group B receives Hepatic Vein Embolization, together with one or more of: Portal Vein 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 358 people.
The study is currently expected to finish around November 2032.
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
Resectability 3 weeks after embolisation — measured over 3 weeks.
Overall survival — measured over 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06914648 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 Portal Vein EmbolizationProcedure
Description: Portal Vein embolization with Glue by a transhepatic approach
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
About Hepatic Vein EmbolizationProcedure
Hepatic Vein Embolization 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 2032-11-15.
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 358 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Montreal, Canada; Ottawa, Canada; Saskatoon, Canada; Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.
Other Sites (2)
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis 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.