Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06914648

The Dragon PLC Trial (DRAGON-PLC)

Led by Maastricht University · Updated on 2025-05-15

358

Participants Needed

55

Research Sites

397 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Dragon PLC Trial (DRAGON-PLC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with primary liver cancer including intrahepatic or perihilar cholangiocarcinoma or hepatocellular carcinoma
  • Requires portal vein embolization due to future liver remnant volume less than 30% for normal livers, less than 40% for livers with potential impairment, or less than 50% for severely impaired livers
  • Future liver remnant function on hepatobiliary scintigraphy below 2.7 %/min/m2
  • Age 18 years or older
  • Able to understand the trial and give informed consent
Not Eligible

You will not qualify if you...

  • Liver cirrhosis with Child-Pugh score B or C
  • Presence of portal hypertension
  • Presence of cholangitis
  • Pregnant women
  • Premenopausal females unable or unwilling to use long-acting or hormonal contraception
  • Unresectable due to serious other health conditions as decided by a medical team
  • Liver cancers other than intrahepatic or perihilar cholangiocarcinoma or hepatocellular carcinoma
  • Anatomical impossibility to perform combined portal and hepatic vein embolization
  • Patients with non-resectable or non-ablatable metastatic disease outside the liver
  • Unable to understand study information or provide informed consent

AI-Screening

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Trial Site Locations

Total: 55 locations

1

Yale School of Medicine Hospital

New Haven, Connecticut, United States, 06510

Not Yet Recruiting

2

Rush University Medical Center

Chicago, Illinois, United States, 60612

Not Yet Recruiting

3

Mayo Clinic

Rochester, Minnesota, United States, 55905

Not Yet Recruiting

4

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Not Yet Recruiting

5

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

6

Monash Medical Center

Melbourne, Australia

Not Yet Recruiting

7

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Not Yet Recruiting

8

Social Center South

Vienna, State of Vienna, Austria, 1100

Not Yet Recruiting

9

Erasmus Hospital

Brussels, Brussels Capital, Belgium, 1070

Not Yet Recruiting

10

UZ Antwerpen

Antwerp, Edegem, Belgium, 2650

Not Yet Recruiting

11

UZ Gent

Ghent, Gent, Belgium, 9000

Not Yet Recruiting

12

CHU Liège

Liège, Liège, Belgium, 4000

Actively Recruiting

13

CHU-UCL Namur site Godinne (UCLouvain)

Yvoir, Namen, Belgium, 5530

Not Yet Recruiting

14

Cliniques Universitaires Saint Luc, UCLouvain

Brussels, Belgium, 1200

Not Yet Recruiting

15

Jessa Hospital

Hasselt, Belgium, 3500

Not Yet Recruiting

16

UZ Brussel

Jette, Belgium, 1090

Not Yet Recruiting

17

AZ Groeninge Hospital Kortrijk

Kortrijk, Belgium, 8500

Not Yet Recruiting

18

Foothills Medical Center

Calgary, Alberta, Canada

Not Yet Recruiting

19

Vancouver General Hospital

Vancouver, British Columbia, Canada

Not Yet Recruiting

20

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Not Yet Recruiting

21

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Not Yet Recruiting

22

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Not Yet Recruiting

23

London Health Sciences Centre

London, Ontario, Canada

Not Yet Recruiting

24

St. Joseph's Health Centre

Toronto, Ontario, Canada

Not Yet Recruiting

25

Sunnybrook Hospital

Toronto, Ontario, Canada

Not Yet Recruiting

26

University Health Network/TGH

Toronto, Ontario, Canada

Not Yet Recruiting

27

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Not Yet Recruiting

28

Centre Hospitalier de l'Université de Montréal

Montreal, Canada

Not Yet Recruiting

29

McGill University Health Centre, Montreal

Montreal, Canada

Not Yet Recruiting

30

L'Hopital d'Ottawa

Ottawa, Canada

Not Yet Recruiting

31

Royal University Hospital

Saskatoon, Canada

Not Yet Recruiting

32

Universitätklinikum Köln

Cologne, Germany

Not Yet Recruiting

33

Universitätklinikum Dresden

Dresden, Germany

Not Yet Recruiting

34

Universitätklinikum Hannover

Hanover, Germany

Not Yet Recruiting

35

Ospedale San Raffaele

Milan, Italy

Not Yet Recruiting

36

Maastricht Universitair Medisch Centrum+

Maastricht, Limburg, Netherlands, 6229HX

Not Yet Recruiting

37

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands

Not Yet Recruiting

38

Maxima Medisch Centrum

Eindhoven, Netherlands

Not Yet Recruiting

39

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Not Yet Recruiting

40

Leiden Universitair Medisch Centrum

Leiden, Netherlands

Not Yet Recruiting

41

University Hospital Oslo

Oslo, Norway

Not Yet Recruiting

42

University Hospital Linköping

Linköping, Sweden

Not Yet Recruiting

43

Karolinska University Hospital Stockholm

Stockholm, Sweden

Not Yet Recruiting

44

Cantonal Hospital Winterthur

Winterthur, Canton of Zurich, Switzerland

Not Yet Recruiting

45

Claraspital Basel

Basel, Switzerland

Not Yet Recruiting

46

Universitätsspital Basel

Basel, Switzerland

Not Yet Recruiting

47

CHUV - Lausanne University Hospital

Lausanne, Switzerland

Not Yet Recruiting

48

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Not Yet Recruiting

49

Hirslanden Klinik

Zurich, Switzerland

Not Yet Recruiting

50

Belfast Health and Social Care Trust

Belfast, United Kingdom

Not Yet Recruiting

51

Queen Elizabeth Hospital

Birmingham, United Kingdom

Not Yet Recruiting

52

Aintree University Hospital

Liverpool, United Kingdom

Not Yet Recruiting

53

Kings college Hospital

London, United Kingdom

Not Yet Recruiting

54

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Not Yet Recruiting

55

University Hospital Southampton

Southampton, United Kingdom

Not Yet Recruiting

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Research Team

F

Fenna A van der Zijden, MSc Technical Medicine

CONTACT

S

Sinead James, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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