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.
1 other identifier
interventional
358
11 countries
54
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2032
May 15, 2025
February 1, 2025
7.6 years
March 21, 2025
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
3 weeks
Overall survival
survival data will be recorded up to 5-years
5 years
Study Arms (2)
Portal Vein Embolization (PVE) - control arm
ACTIVE COMPARATORPortal Vein Embolization (PVE) alone
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional arm
EXPERIMENTALCombined Portal and Hepatic Vein Embolization (PVE/HVE)
Interventions
Description: Portal Vein embolization with Glue by a transhepatic approach
Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Yale School of Medicine Hospital
New Haven, Connecticut, 06510, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Monash Medical Center
Melbourne, Australia
Medical University of Vienna
Vienna, Vienna, 1090, Austria
Social Center South
Vienna, Vienna, 1100, Austria
Erasmus Hospital
Brussels, Brussels Capital, 1070, Belgium
UZ Antwerpen
Antwerp, Edegem, 2650, Belgium
UZ Gent
Ghent, Gent, 9000, Belgium
CHU Liège
Liège, Liège, 4000, Belgium
CHU-UCL Namur site Godinne (UCLouvain)
Yvoir, Namen, 5530, Belgium
Cliniques Universitaires Saint Luc, UCLouvain
Brussels, 1200, Belgium
Jessa Hospital
Hasselt, 3500, Belgium
UZ Brussel
Jette, 1090, Belgium
AZ Groeninge Hospital Kortrijk
Kortrijk, 8500, Belgium
Foothills Medical Center
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
University Health Network/TGH
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
McGill University Health Centre, Montreal
Montreal, Canada
L'Hopital d'Ottawa
Ottawa, Canada
Royal University Hospital
Saskatoon, Canada
Universitätklinikum Köln
Cologne, Germany
Universitätklinikum Dresden
Dresden, Germany
Universitätklinikum Hannover
Hanover, Germany
Ospedale San Raffaele
Milan, Italy
Maastricht Universitair Medisch Centrum+
Maastricht, Limburg, 6229HX, Netherlands
Amsterdam UMC, location VUMC
Amsterdam, North Holland, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Leiden Universitair Medisch Centrum
Leiden, Netherlands
University Hospital Oslo
Oslo, Norway
University Hospital Linköping
Linköping, Sweden
Karolinska University Hospital Stockholm
Stockholm, Sweden
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, Switzerland
Claraspital Basel
Basel, Switzerland
Universitätsspital Basel
Basel, Switzerland
CHUV - Lausanne University Hospital
Lausanne, Switzerland
Hirslanden Klinik St. Anna
Lucerne, Switzerland
Hirslanden Klinik
Zurich, Switzerland
Belfast Health and Social Care Trust
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Kings college Hospital
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2025
First Posted
April 6, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
November 15, 2032
Study Completion (Estimated)
November 15, 2032
Last Updated
May 15, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After publication
- Access Criteria
- Proposal accepted by the DRAGON Collaborative Scientific Committee
Upon reasonable request