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Primary Liver CancerNCT06914648

The Dragon PLC Trial (DRAGON-PLC)

A study testing Portal Vein Embolization and Hepatic Vein Embolization in people with Primary Liver Cancer and Hepatocellular Carcinoma (HCC), run by Maastricht University at 55 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Portal Vein Embolization and Hepatic Vein Embolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
55 sitesin 12 countries
Study dates
1 Apr 2025to 15 Nov 2032
Phase
Interventional
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

Who may be able to join

  • 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;
  • Age ≥ 18 years;
  • Able to understand the trial and provide informed consent.

Who cannot join

  • Liver cirrhosis with a Child-Pugh score of B or C;
  • Presence of portal hypertension;
  • Presence of cholangitis;
  • Pregnant women;
  • Premenopausal females not able/willing to commit to contraception (specifically long-acting reversible contraception or hormonal contraception);
  • Patients unresectable due to prohibitive comorbidities (decision made by local multidisciplinary team);
Show all 10Show fewer
  • 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 consent

Trial locations and contacts

55 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Fenna A van der Zijden, MSc Technical Medicine contact

+31640911632

fenna.van.der.zijden@mumc.nl

Sinead James, MD contact

+31 638463945

sinead.james@mumc.nl

55 sites in 12 countries

Canada14 sites, 14 recruiting
  • Foothills Medical Center

    Calgary, Alberta

    C. Ball, Dr.

    Not yet recruiting
  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia

    M. Walsh, Dr.

    C. Lightfoot, Dr.

    Not yet recruiting
  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario

    L. Ruo, Dr.

    G. Markose, Dr.

    Not yet recruiting
  • Kingston Health Sciences Centre

    Kingston, Ontario

    S. Bennet, Dr.

    A. Menard, Dr.

    Not yet recruiting
  • London Health Sciences Centre

    London, Ontario

    A. Skaro, Dr.

    A. Mujoomdar, Dr.

    Not yet recruiting
  • Centre Hospitalier de l'Université de Montréal

    Montreal

    Franck Vandenbroucke-Menu, Dr.

    Franck Vandenbroucke-Menu, Dr.

    Not yet recruiting
  • McGill University Health Centre, Montreal

    Montreal

    Peter Metrakos, Prof. Dr.

    Peter Metrakos, Prof. Dr.

    Not yet recruiting
  • L'Hopital d'Ottawa

    Ottawa

    Guillaume Martel, Dr.

    Guillaume Martel, Dr.

    Not yet recruiting
  • Royal University Hospital

    Saskatoon

    M. Moser, Dr.

    M. Wright, Dr.

    Not yet recruiting
  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec

    Dr. Y. Collin, Dr.

    Dr. Y. Collin, Dr.

    Not yet recruiting
  • St. Joseph's Health Centre

    Toronto, Ontario

    S. Jayaraman, Dr.

    Not yet recruiting
  • Sunnybrook Hospital

    Toronto, Ontario

    P. Karanicolas, Dr.

    G. Maroune, Dr.

    Not yet recruiting
  • University Health Network/TGH

    Toronto, Ontario

    S. Gallinger, Dr.

    Not yet recruiting
  • Vancouver General Hospital

    Vancouver, British Columbia

    M. Segedi, Dr.

    D. Klass, Dr.

    Not yet recruiting

Other trials in Canada

Belgium9 sites, 9 recruiting
  • UZ Antwerpen

    Antwerp, Edegem, 2650

    Thiery Chapelle, Dr.

    Thomas Jardinet, Dr.

    Not yet recruiting
  • Erasmus Hospital

    Brussels, Brussels Capital, 1070

    Valerio Lucidi, Dr.

    Illario Tancredi, Dr.

    Not yet recruiting
  • Cliniques Universitaires Saint Luc, UCLouvain

    Brussels, 1200

    Laurent Coubeau, Dr.

    Laurent Coubeau, Dr.

    Not yet recruiting
  • UZ Gent

    Ghent, Gent, 9000

    T. Chapell, Prof. Dr.

    Thiery Chapelle, Prof. Dr.

    Not yet recruiting
  • Jessa Hospital

    Hasselt, 3500

    Gregory Sergeant, Dr.

    Gregory Sergeant, Dr.

    Not yet recruiting
  • UZ Brussel

    Jette, 1090

    Nouredin Messaoudi, Prof. Dr.

    Nouredin Messaoudi, Prof. Dr.

    Not yet recruiting
  • AZ Groeninge Hospital Kortrijk

    Kortrijk, 8500

    Mathieu D'Hondt, Dr.

    Mathieu D'Hondt, Dr

    Not yet recruiting
  • CHU Liège

    Liège, Liège, 4000

    Celine Lambrecht

    Axelle Bertrand

    Recruiting
  • CHU-UCL Namur site Godinne (UCLouvain)

    Yvoir, Namen, 5530

    Alexandra Dili, Dr

    Hadrien Fourneau, Dr.

    Not yet recruiting

Other trials in Belgium

Switzerland6 sites, 6 recruiting
  • Claraspital Basel

    Basel

    O. Kollmar, Prof.

    M. Hoffmann, Prof.

    Not yet recruiting
  • Universitätsspital Basel

    Basel

    O. Kollmar, Prof.

    M. Hoffmann, Prof.

    Not yet recruiting
  • CHUV - Lausanne University Hospital

    Lausanne

    E. Melloul, Dr.

    A. Denys, Prof.

    Not yet recruiting
  • Hirslanden Klinik St. Anna

    Lucerne

    E. Schadde, Prof.

    Not yet recruiting
  • Cantonal Hospital Winterthur

    Winterthur, Canton of Zurich

    L.F. Grochola, Dr.

    C.A. Binkert, Prof.

    Not yet recruiting
  • Hirslanden Klinik

    Zurich

    M. Schiesser, Prof.

    Not yet recruiting

Other trials in Switzerland

United Kingdom6 sites, 6 recruiting
  • Belfast Health and Social Care Trust

    Belfast

    D.G. Vass, Dr.

    Not yet recruiting
  • Queen Elizabeth Hospital

    Birmingham

    R. Sutcliffe, Dr.

    H. Mehrzad, Dr.

    Not yet recruiting
  • Aintree University Hospital

    Liverpool

    R. Díaz-Nieto, Dr.

    R. Davis

    Not yet recruiting
  • Kings college Hospital

    London

    K. Menon, Dr.

    P. Peddu, Dr.

    Not yet recruiting
  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    K.V. Udupa

    A. MacDonald, Dr.

    Not yet recruiting
  • University Hospital Southampton

    Southampton

    J.N. Primrose, Prof.

    D. Breen

    Not yet recruiting

Other trials in United Kingdom

United States5 sites, 5 recruiting
  • Rush University Medical Center

    Chicago, Illinois, 60612

    M. Dixon, Dr.

    B. Arslan, Dr.

    Not yet recruiting
  • Cleveland Clinic

    Cleveland, Ohio, 44195

    D. Kwon, Prof.

    S. Gadani, Prof.

    Not yet recruiting
  • Yale School of Medicine Hospital

    New Haven, Connecticut, 06510

    K. Billingsley, Prof.

    D.C. Madoff, Prof.

    Not yet recruiting
  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    T.P. Kingham, Prof.

    F. Riduani, Dr.

    Not yet recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55905

    P. Starlinger, Dr.

    Not yet recruiting

Other trials in United States

Netherlands5 sites, 5 recruiting
  • Amsterdam UMC, location VUMC

    Amsterdam, North Holland

    Joris I Erdmann, Dr.

    IJsbrand Zijlstra, Dr.

    Not yet recruiting
  • Maxima Medisch Centrum

    Eindhoven

    Wouter K.G. Leclercq, Dr.

    Laurens J. van Baardewijk, Dr.

    Not yet recruiting
  • Universitair Medisch Centrum Groningen

    Groningen

    Suomi M.G. Furaschen, Dr.

    Reinoud P.H. Bokkers, Dr.

    Not yet recruiting
  • Leiden Universitair Medisch Centrum

    Leiden

    Dries A.E. Braat, Dr.

    Mark Burgmans, Dr.

    Not yet recruiting
  • Maastricht Universitair Medisch Centrum+

    Maastricht, Limburg, 6229HX

    Fenna A van der Zijden, MSc, +31640911632, fenna.van.der.zijden@mumc.nl

    Sinead James, MD, +31638463945, sinead.james@mumc.nl

    Not yet recruiting

Other trials in Netherlands

Germany3 sites, 3 recruiting
  • Universitätklinikum Köln

    Cologne

    C. Bruns, Prof.

    A. Bunck, Prof.

    Not yet recruiting
  • Universitätklinikum Dresden

    Dresden

    J. Weitz, Prof.

    Not yet recruiting
  • Universitätklinikum Hannover

    Hanover

    M. Schmelzle, Prof.

    F. Wacker, Prof.

    Not yet recruiting

Other trials in Germany

Austria2 sites, 2 recruiting
  • Medical University of Vienna

    Vienna, State of Vienna, 1090

    Klaus Kaczirek, Prof. Dr.

    Florian Wolf, Dr.

    Not yet recruiting
  • Social Center South

    Vienna, State of Vienna, 1100

    Thomas Gruenberger, Prof.

    Irena I. Baclija, Dr.

    Not yet recruiting

Other trials in Austria

Sweden2 sites, 2 recruiting
  • University Hospital Linköping

    Linköping

    P. Sandström, Prof.

    A. Erbahceci Salik, Dr.

    Not yet recruiting
  • Karolinska University Hospital Stockholm

    Stockholm

    E. Sparrelid, Dr.

    M. Delle, Dr.

    Not yet recruiting

Other trials in Sweden

Australia1 site, 1 recruiting
  • Monash Medical Center

    Melbourne

    Diederick de Boo

    Daniel Croagh, Dr.

    Not yet recruiting

Other trials in Australia

Italy1 site, 1 recruiting
  • Ospedale San Raffaele

    Milan

    L.A. Aldrighetti, Prof.

    F. De Cobelli, Dr.

    Not yet recruiting

Other trials in Italy

Norway1 site, 1 recruiting
  • University Hospital Oslo

    Oslo

    Å. Fretland, Dr.

    U. Carling, Dr.

    Not yet recruiting

Other trials in Norway

About this study

Official title: 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.

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.

Read more

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.
Read the detailed description

Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and >70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver.

This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs.

Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.

Being tested
Portal Vein Embolization, Hepatic Vein Embolization
Keywords
Primary liver cancer, Future Liver Remnant, Liver regeneration, Portal Vein Embolization (PVE), Hepatic Vein Embolization (HVE)
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portal Vein EmbolizationProcedure or surgery

    Description: Portal Vein embolization with Glue by a transhepatic approach

  • Hepatic Vein EmbolizationProcedure or surgery

    Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Study groups in NCT06914648
Study groupRoleWhat they receive
Portal Vein Embolization (PVE) - control armActive comparatorPortal Vein Embolization (PVE) alone
Receives: Procedure: Portal Vein Embolization
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional armExperimentalCombined Portal and Hepatic Vein Embolization (PVE/HVE)
Receives: Procedure: Portal Vein Embolization; Procedure: Hepatic Vein Embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resectability 3 weeks after embolisation

    The FLR is considered sufficient for resection 3 weeks after embolisation. Definition resectable: Patients are deemed resectable if the FLR is ≥30% in normally functioning livers, ≥40% in livers with potentially impaired function (e.g. resulting from prior systemic therapy or bile duct colonization / transpapillary biliary drainage), or ≥50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR for any FLR volume, function on hepatobiliary scintigraphy is > 2.7 %/min/m2

    Measured: 3 weeks

  2. Overall survival

    survival data will be recorded up to 5-years

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion15 Nov 2032 (estimated)
  4. Study completion15 Nov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Randomization between control and interventional group
Masking
None (open label)
Enrolment
358 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914648
Sponsor's protocol ID
NL87590.0681.24
Status last verified
Feb 2025
First submitted
21 Mar 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon reasonable request

Questions about this trial

What is this clinical trial studying?

A study testing Portal Vein Embolization and Hepatic Vein Embolization in people with Primary Liver Cancer and Hepatocellular Carcinoma (HCC), run by Maastricht University at 55 sites in 12 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 4 inclusion and 10 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Canada, Belgium, Switzerland, United Kingdom, United States and 7 more countries. 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 Fenna A van der Zijden, MSc Technical Medicine (+31640911632, fenna.van.der.zijden@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resectability 3 weeks after embolisation (time frame: 3 weeks). 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 15 May 2025.

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