RecruitingNot ApplicableNCT06914648

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.

Sponsor

Maastricht University

Enrollment

358 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Hepatocellular Carcinoma (HCC)Primary Liver Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways to stimulate liver regrowth before major liver surgery for liver cancer: a standard procedure called portal vein embolization (PVE) versus a combined procedure that also targets the hepatic vein (PVE + HVE), to see which better increases the remaining liver volume. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a primary liver cancer (intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or hepatocellular carcinoma) - You need a liver-stimulating procedure because your remaining liver volume is too small for safe surgery - Your liver function is adequate (not severely cirrhotic) **You may NOT be eligible if...** - You have liver cirrhosis that is classified as Child-Pugh B or C (moderate-to-severe) - You have portal hypertension or active bile duct infection - You are pregnant or unable to use contraception - Your cancer has spread outside the liver in a way that cannot be treated - The procedure is not technically possible due to your anatomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPortal Vein Embolization

Description: Portal Vein embolization with Glue by a transhepatic approach

PROCEDUREHepatic Vein Embolization

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

Locations(55)

Yale School of Medicine Hospital

New Haven, Connecticut, United States

Rush University Medical Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Monash Medical Center

Melbourne, Australia

Medical University of Vienna

Vienna, State of Vienna, Austria

Social Center South

Vienna, State of Vienna, Austria

Erasmus Hospital

Brussels, Brussels Capital, Belgium

UZ Antwerpen

Antwerp, Edegem, Belgium

UZ Gent

Ghent, Gent, Belgium

CHU Liège

Liège, Liège, Belgium

CHU-UCL Namur site Godinne (UCLouvain)

Yvoir, Namen, Belgium

Cliniques Universitaires Saint Luc, UCLouvain

Brussels, Belgium

Jessa Hospital

Hasselt, Belgium

UZ Brussel

Jette, Belgium

AZ Groeninge Hospital Kortrijk

Kortrijk, 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, 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

View Full Details on ClinicalTrials.gov

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NCT06914648

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