The Dragon PLC Trial (DRAGON-PLC)

May 12, 2025 updated by: Maastricht University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Not yet recruiting
        • Monash Medical Center
        • Contact:
          • Diederick de Boo
        • Principal Investigator:
          • Daniel Croagh, Dr.
        • Principal Investigator:
          • Diedrick de Boo, Dr.
  • Austria
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Klaus Kaczirek, Prof. Dr.
        • Principal Investigator:
          • Florian Wolf, Dr.
      • Vienna, Austria, 1100
        • Not yet recruiting
        • Social Center South
        • Principal Investigator:
          • Thomas Gruenberger, Prof.
        • Principal Investigator:
          • Irena I. Baclija, Dr.
  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint Luc, UCLouvain
        • Contact:
          • Laurent Coubeau, Dr.
        • Principal Investigator:
          • Laurent Coubeau, Dr.
        • Principal Investigator:
          • Pierre Goffette, Dr
      • Gent, Belgium, 9000
        • Not yet recruiting
        • UZ Gent
        • Principal Investigator:
          • Thomas Jardinet, Dr.
        • Contact:
          • T. Chapell, Prof. Dr.
        • Principal Investigator:
          • Thiery Chapelle, Prof. Dr.
      • Hasselt, Belgium, 3500
        • Not yet recruiting
        • Jessa Hospital
        • Contact:
          • Gregory Sergeant, Dr.
        • Principal Investigator:
          • Gregory Sergeant, Dr.
        • Principal Investigator:
          • Sam Heye, Dr.
      • Jette, Belgium, 1090
        • Not yet recruiting
        • UZ Brussel
        • Contact:
          • Nouredin Messaoudi, Prof. Dr.
        • Principal Investigator:
          • Nouredin Messaoudi, Prof. Dr.
        • Principal Investigator:
          • Frans van den Bergh, Dr.
      • Kortrijk, Belgium, 8500
        • Not yet recruiting
        • AZ Groeninge Hospital Kortrijk
        • Contact:
          • Mathieu D'Hondt, Dr.
        • Principal Investigator:
          • Olivier Francois, Dr
        • Principal Investigator:
          • Mathieu D'Hondt, Dr
      • Liège, Belgium, 4000
        • Recruiting
        • Chu Liege
        • Contact:
          • Celine Lambrecht
        • Contact:
          • Axelle Bertrand
        • Principal Investigator:
          • Olivier Detry, Dr.
        • Principal Investigator:
          • Laurent Gerard, Dr.
    • Bruxelles
      • Brussels, Bruxelles, Belgium, 1070
        • Not yet recruiting
        • Erasmus Hospital
        • Principal Investigator:
          • Valerio Lucidi, Dr.
        • Principal Investigator:
          • Illario Tancredi, Dr.
    • Edegem
      • Antwerp, Edegem, Belgium, 2650
        • Not yet recruiting
        • UZ Antwerpen
        • Principal Investigator:
          • Thiery Chapelle, Dr.
        • Principal Investigator:
          • Thomas Jardinet, Dr.
    • Namen
      • Yvoir, Namen, Belgium, 5530
        • Not yet recruiting
        • CHU-UCL Namur site Godinne (UCLouvain)
        • Principal Investigator:
          • Alexandra Dili, Dr
        • Principal Investigator:
          • Hadrien Fourneau, Dr.
  • Canada
      • Montreal, Canada
        • Not yet recruiting
        • Centre hospitalier de l'Université de Montréal
        • Contact:
          • Franck Vandenbroucke-Menu, Dr.
        • Principal Investigator:
          • Franck Vandenbroucke-Menu, Dr.
        • Principal Investigator:
          • Pierre Perrault, Dr.
      • Montreal, Canada
        • Not yet recruiting
        • McGill University Health Centre, Montreal
        • Contact:
          • Peter Metrakos, Prof. Dr.
        • Principal Investigator:
          • Peter Metrakos, Prof. Dr.
        • Principal Investigator:
          • David Valenti, Dr.
      • Ottawa, Canada
        • Not yet recruiting
        • L'Hopital d'Ottawa
        • Contact:
          • Guillaume Martel, Dr.
        • Principal Investigator:
          • Guillaume Martel, Dr.
        • Principal Investigator:
          • Stephen Ryan, Dr.
      • Saskatoon, Canada
        • Not yet recruiting
        • Royal University Hospital
        • Principal Investigator:
          • M. Moser, Dr.
        • Principal Investigator:
          • M. Wright, Dr.
    • Alberta
      • Calgary, Alberta, Canada
        • Not yet recruiting
        • Foothills Medical Center
        • Principal Investigator:
          • C. Ball, Dr.
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Not yet recruiting
        • Vancouver General Hospital
        • Principal Investigator:
          • M. Segedi, Dr.
        • Principal Investigator:
          • D. Klass, Dr.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Not yet recruiting
        • Queen Elizabeth II Health Sciences Center
        • Principal Investigator:
          • M. Walsh, Dr.
        • Principal Investigator:
          • C. Lightfoot, Dr.
    • Ontario
      • Hamilton, Ontario, Canada
        • Not yet recruiting
        • Juravinski Hospital and Cancer Centre
        • Principal Investigator:
          • L. Ruo, Dr.
        • Principal Investigator:
          • G. Markose, Dr.
      • Kingston, Ontario, Canada
        • Not yet recruiting
        • Kingston Health Sciences Centre
        • Principal Investigator:
          • S. Bennet, Dr.
        • Principal Investigator:
          • A. Menard, Dr.
      • London, Ontario, Canada
        • Not yet recruiting
        • London Health Sciences Centre
        • Principal Investigator:
          • A. Skaro, Dr.
        • Principal Investigator:
          • A. Mujoomdar, Dr.
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • St. Joseph's Health Centre
        • Principal Investigator:
          • S. Jayaraman, Dr.
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Sunnybrook Hospital
        • Principal Investigator:
          • P. Karanicolas, Dr.
        • Principal Investigator:
          • G. Maroune, Dr.
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • University Health Network/TGH
        • Principal Investigator:
          • S. Gallinger, Dr.
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
          • Dr. Y. Collin, Dr.
        • Principal Investigator:
          • Dr. Y. Collin, Dr.
        • Principal Investigator:
          • Dr. M. Noel-Lamy, Dr.
  • Germany
      • Dresden, Germany
        • Not yet recruiting
        • Universitätklinikum Dresden
        • Principal Investigator:
          • J. Weitz, Prof.
      • Hannover, Germany
        • Not yet recruiting
        • Universitätklinikum Hannover
        • Principal Investigator:
          • M. Schmelzle, Prof.
        • Principal Investigator:
          • F. Wacker, Prof.
      • Köln, Germany
        • Not yet recruiting
        • Universitätklinikum Köln
        • Principal Investigator:
          • C. Bruns, Prof.
        • Principal Investigator:
          • A. Bunck, Prof.
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • L.A. Aldrighetti, Prof.
        • Principal Investigator:
          • F. De Cobelli, Dr.
  • Netherlands
      • Eindhoven, Netherlands
        • Not yet recruiting
        • Maxima Medisch Centrum
        • Principal Investigator:
          • Wouter K.G. Leclercq, Dr.
        • Principal Investigator:
          • Laurens J. van Baardewijk, Dr.
      • Groningen, Netherlands
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
        • Principal Investigator:
          • Suomi M.G. Furaschen, Dr.
        • Principal Investigator:
          • Reinoud P.H. Bokkers, Dr.
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden Universitair Medisch Centrum
        • Principal Investigator:
          • Dries A.E. Braat, Dr.
        • Principal Investigator:
          • Mark Burgmans, Dr.
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Not yet recruiting
        • Maastricht Universitair Medisch Centrum+
        • Principal Investigator:
          • Ronald M van Dam, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fenna A van der Zijden, MSc
        • Sub-Investigator:
          • Sinead James, MD
        • Principal Investigator:
          • Christiaan van der Leij, Dr.
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands
        • Not yet recruiting
        • Amsterdam UMC, location VUmc
        • Principal Investigator:
          • Joris I Erdmann, Dr.
        • Principal Investigator:
          • IJsbrand Zijlstra, Dr.
  • Norway
      • Oslo, Norway
        • Not yet recruiting
        • university Hospital Oslo
        • Principal Investigator:
          • Å. Fretland, Dr.
        • Principal Investigator:
          • U. Carling, Dr.
  • Sweden
      • Linköping, Sweden
        • Not yet recruiting
        • University Hospital Linköping
        • Principal Investigator:
          • P. Sandström, Prof.
        • Principal Investigator:
          • A. Erbahceci Salik, Dr.
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska University Hospital Stockholm
        • Principal Investigator:
          • E. Sparrelid, Dr.
        • Principal Investigator:
          • M. Delle, Dr.
  • Switzerland
      • Basel, Switzerland
        • Not yet recruiting
        • Universitatsspital Basel
        • Principal Investigator:
          • O. Kollmar, Prof.
        • Principal Investigator:
          • M. Hoffmann, Prof.
      • Basel, Switzerland
        • Not yet recruiting
        • Claraspital Basel
        • Principal Investigator:
          • O. Kollmar, Prof.
        • Principal Investigator:
          • M. Hoffmann, Prof.
      • Lausanne, Switzerland
        • Not yet recruiting
        • CHUV - Lausanne University Hospital
        • Principal Investigator:
          • E. Melloul, Dr.
        • Principal Investigator:
          • A. Denys, Prof.
      • Luzern, Switzerland
        • Not yet recruiting
        • Hirslanden Klinik St. Anna
        • Principal Investigator:
          • E. Schadde, Prof.
      • Zürich, Switzerland
        • Not yet recruiting
        • Hirslanden Klinik
        • Principal Investigator:
          • M. Schiesser, Prof.
    • Zürich
      • Winterthur, Zürich, Switzerland
        • Not yet recruiting
        • Cantonal Hospital Winterthur
        • Principal Investigator:
          • L.F. Grochola, Dr.
        • Principal Investigator:
          • C.A. Binkert, Prof.
  • United Kingdom
      • Belfast, United Kingdom
        • Not yet recruiting
        • Belfast Health and Social Care Trust
        • Principal Investigator:
          • D.G. Vass, Dr.
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • R. Sutcliffe, Dr.
        • Principal Investigator:
          • H. Mehrzad, Dr.
      • Liverpool, United Kingdom
        • Not yet recruiting
        • Aintree University Hospital
        • Principal Investigator:
          • R. Díaz-Nieto, Dr.
        • Principal Investigator:
          • R. Davis
      • London, United Kingdom
        • Not yet recruiting
        • Kings College Hospital
        • Principal Investigator:
          • K. Menon, Dr.
        • Principal Investigator:
          • P. Peddu, Dr.
      • Oxford, United Kingdom
        • Not yet recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • K.V. Udupa
        • Principal Investigator:
          • A. MacDonald, Dr.
      • Southampton, United Kingdom
        • Not yet recruiting
        • University Hospital Southampton
        • Principal Investigator:
          • J.N. Primrose, Prof.
        • Principal Investigator:
          • D. Breen
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Yale School of Medicine Hospital
        • Principal Investigator:
          • K. Billingsley, Prof.
        • Principal Investigator:
          • D.C. Madoff, Prof.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • M. Dixon, Dr.
        • Principal Investigator:
          • B. Arslan, Dr.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Principal Investigator:
          • P. Starlinger, Dr.
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • T.P. Kingham, Prof.
        • Principal Investigator:
          • F. Riduani, Dr.
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • D. Kwon, Prof.
        • Principal Investigator:
          • S. Gadani, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Portal Vein Embolization (PVE) - control arm
Portal Vein Embolization (PVE) alone
Procedure: Portal Vein Embolization
Description: Portal Vein embolization with Glue by a transhepatic approach
Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional arm
Combined Portal and Hepatic Vein Embolization (PVE/HVE)
Procedure: Portal Vein Embolization
Description: Portal Vein embolization with Glue by a transhepatic approach
Procedure: Hepatic Vein Embolization
Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resectability 3 weeks after embolisation
Time Frame: 3 weeks
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
3 weeks
Overall survival
Time Frame: 5 years
survival data will be recorded up to 5-years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

November 15, 2032

Study Completion (Estimated)

November 15, 2032

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL87590.0681.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Proposal accepted by the DRAGON Collaborative Scientific Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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