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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (55)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Social Center South Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Monash Medical Center Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| UZ Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Not yet recruiting |
| Erasmus Hospital Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| Cliniques universitaires Saint-Luc - UCLouvain Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| Jessa Hospital Coordinator of this site? Confirm its status | Hasselt | Belgium | Not yet recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Not yet recruiting |
| AZ Groeninge Hospital Kortrijk Coordinator of this site? Confirm its status | Kortrijk | Belgium | Not yet recruiting |
| CHU Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| CHU-UCL Namur site Godinne (UCLouvain) Coordinator of this site? Confirm its status | Yvoir | Belgium | Not yet recruiting |
| Foothills Medical Center Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Queen Elizabeth II Health Sciences Center Coordinator of this site? Confirm its status | Halifax | Canada | Not yet recruiting |
| Juravinski Hospital and Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Not yet recruiting |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| McGill University Health Centre, Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| L'Hopital d'Ottawa Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| Royal University Hospital Coordinator of this site? Confirm its status | Saskatoon | Canada | Not yet recruiting |
| Centre Hospitalier Universitaire de Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Not yet recruiting |
| St. Joseph's Health Centre Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Sunnybrook Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| University Health Network/TGH Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
| Claraspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Not yet recruiting |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Not yet recruiting |
| Chuv, Lausanne University Hospital Coordinator of this site? Confirm its status | Lausanne | Switzerland | Not yet recruiting |
| Hirslanden Klinik St. Anna Coordinator of this site? Confirm its status | Lucerne | Switzerland | Not yet recruiting |
| Cantonal Hospital Winterthur Coordinator of this site? Confirm its status | Winterthur | Switzerland | Not yet recruiting |
| Hirslanden Klinik Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Universitätklinikum Köln Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Universitätklinikum Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Universitätklinikum Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| Belfast Health and Social Care Trust Coordinator of this site? Confirm its status | Belfast | United Kingdom | Not yet recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Aintree University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Not yet recruiting |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Not yet recruiting |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Not yet recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Máxima Medisch Centrum Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Leiden Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Maastricht Universitair Medisch Centrum Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| University Hospital Oslo Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| University Hospital Linköping Coordinator of this site? Confirm its status | Linköping | Sweden | Not yet recruiting |
| Karolinska University Hospital Stockholm Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Yale School of Medicine Hospital Coordinator of this site? Confirm its status | New Haven | United States | Not yet recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.