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NCT06914648Recruiting

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.

Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
358 (estimated)
First submitted
21 Mar 2025
Start date
1 Apr 2025
Primary completion date
15 Nov 2032
Lead sponsor
Maastricht University
NCT number
NCT06914648

What you commit to

  • Study type: Interventional
  • Planned participants: 358
  • From 1 Apr 2025 to the primary completion date, 15 Nov 2032
  • 55 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of portal hypertension;
  • Patients with hepatic malignancies other than iCCC, pCCC or HCC;
  • Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.

Other

  • Liver cirrhosis with a Child-Pugh score of B or C;
  • 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);
  • PVE/HVE anatomically not feasible;
  • Unable to understand the study information, study instructions and give informed consent

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (55)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
Coordinator of this site? Confirm its status
ViennaAustriaNot yet recruiting
Social Center South
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ViennaAustriaNot yet recruiting
Monash Medical Center
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MelbourneAustraliaNot yet recruiting
UZ Antwerpen
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AntwerpBelgiumNot yet recruiting
Erasmus Hospital
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BrusselsBelgiumNot yet recruiting
Cliniques universitaires Saint-Luc - UCLouvain
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BrusselsBelgiumNot yet recruiting
UZ Gent
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GhentBelgiumNot yet recruiting
Jessa Hospital
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HasseltBelgiumNot yet recruiting
UZ Brussel
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JetteBelgiumNot yet recruiting
AZ Groeninge Hospital Kortrijk
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KortrijkBelgiumNot yet recruiting
CHU Liège
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LiègeBelgiumRecruiting
CHU-UCL Namur site Godinne (UCLouvain)
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YvoirBelgiumNot yet recruiting
Foothills Medical Center
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CalgaryCanadaNot yet recruiting
Queen Elizabeth II Health Sciences Center
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HalifaxCanadaNot yet recruiting
Juravinski Hospital and Cancer Centre
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HamiltonCanadaNot yet recruiting
Kingston Health Sciences Centre
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KingstonCanadaNot yet recruiting
London Health Sciences Centre
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LondonCanadaNot yet recruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaNot yet recruiting
McGill University Health Centre, Montreal
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MontrealCanadaNot yet recruiting
L'Hopital d'Ottawa
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OttawaCanadaNot yet recruiting
Royal University Hospital
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SaskatoonCanadaNot yet recruiting
Centre Hospitalier Universitaire de Sherbrooke
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SherbrookeCanadaNot yet recruiting
St. Joseph's Health Centre
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TorontoCanadaNot yet recruiting
Sunnybrook Hospital
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TorontoCanadaNot yet recruiting
University Health Network/TGH
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TorontoCanadaNot yet recruiting
Vancouver General Hospital
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VancouverCanadaNot yet recruiting
Claraspital Basel
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BaselSwitzerlandNot yet recruiting
Universitätsspital Basel
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BaselSwitzerlandNot yet recruiting
Chuv, Lausanne University Hospital
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LausanneSwitzerlandNot yet recruiting
Hirslanden Klinik St. Anna
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LucerneSwitzerlandNot yet recruiting
Cantonal Hospital Winterthur
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WinterthurSwitzerlandNot yet recruiting
Hirslanden Klinik
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ZurichSwitzerlandNot yet recruiting
Universitätklinikum Köln
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CologneGermanyNot yet recruiting
Universitätklinikum Dresden
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DresdenGermanyNot yet recruiting
Universitätklinikum Hannover
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HanoverGermanyNot yet recruiting
Belfast Health and Social Care Trust
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BelfastUnited KingdomNot yet recruiting
Queen Elizabeth Hospital
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BirminghamUnited KingdomNot yet recruiting
Aintree University Hospital
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LiverpoolUnited KingdomNot yet recruiting
Kings College Hospital
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LondonUnited KingdomNot yet recruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomNot yet recruiting
University Hospital Southampton
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SouthamptonUnited KingdomNot yet recruiting
Ospedale San Raffaele
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MilanItalyNot yet recruiting
Amsterdam UMC location VUmc
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AmsterdamNetherlandsNot yet recruiting
Máxima Medisch Centrum
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EindhovenNetherlandsNot yet recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsNot yet recruiting
Leiden Universitair Medisch Centrum
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LeidenNetherlandsNot yet recruiting
Maastricht Universitair Medisch Centrum
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MaastrichtNetherlandsNot yet recruiting
University Hospital Oslo
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OsloNorwayNot yet recruiting
University Hospital Linköping
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LinköpingSwedenNot yet recruiting
Karolinska University Hospital Stockholm
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StockholmSwedenNot yet recruiting
Rush University Medical Center
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ChicagoUnited StatesNot yet recruiting
Cleveland Clinic
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ClevelandUnited StatesNot yet recruiting
Yale School of Medicine Hospital
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New HavenUnited StatesNot yet recruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesNot yet recruiting
Mayo Clinic
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RochesterUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.