Actively Recruiting
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.
Led by Maastricht University · Updated on 2025-05-15
358
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether combining portal vein embolization (PVE) with hepatic vein embolization (HVE) improves the chances of liver surgery and overall survival in patients with initially unresectable primary liver cancers, including hepatocellular carcinoma and cholangiocarcinoma. The trial aims to see if this combined approach increases liver growth and makes surgery possible within 3 weeks, and whether it improves survival over 5 years compared to standard PVE alone. Participants will receive either standard PVE or the combined PVE and HVE procedure. PVE involves blocking blood flow to part of the liver to encourage growth of the remaining liver, while HVE adds blockage of the hepatic vein during the same session. These procedures are done using specific techniques like a transhepatic approach for PVE and transjugular or transfemoral approaches for HVE. The study compares these two approaches to see which better supports liver growth and surgery readiness. Throughout the study, participants will undergo regular imaging to check liver growth and resectability. Researchers will monitor survival outcomes for up to 5 years after the embolization procedures. The main outcomes measured include the proportion of patients able to have surgery within 3 weeks and overall survival at 5 years. The study also tracks safety and liver function to ensure participants' well-being during and after treatment.
CONDITIONS
Brief Title
The Dragon PLC Trial (DRAGON-PLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary liver cancer, specifically intrahepatic cholangiocarcinoma (iCCC), perihilar cholangiocarcinoma (pCCC), or hepatocellular carcinoma (HCC)
- Requiring portal vein embolization (PVE) due to future liver remnant (FLR) volume less than 30% in normally functioning livers
- Requiring PVE due to FLR less than 40% in livers with potentially impaired function (e.g., prior systemic therapy or bile duct drainage)
- Requiring PVE due to FLR less than 50% in livers with severely impaired function from liver cirrhosis (maximum Child-Pugh A5)
- Alternatively, FLR function on hepatobiliary scintigraphy (HEBIS) less than 2.7 %/min/m2
- Age 18 years or older
- Able to understand the trial and provide informed consent
You will not qualify if you...
- Liver cirrhosis with Child-Pugh score of B or C
- Presence of portal hypertension
- Presence of cholangitis
- Pregnant women
- Premenopausal females not able or willing to commit to contraception (long-acting reversible or hormonal)
- Patients deemed unresectable due to prohibitive comorbidities by local multidisciplinary team
- Patients with hepatic malignancies other than iCCC, pCCC, or HCC
- Anatomical infeasibility of PVE/HVE
- Presence of non-resectable or non-ablatable extrahepatic metastatic disease
- Unable to understand study information, instructions, or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Up to 3 weeks until assessment for surgical resectability
Participants undergo either Portal Vein Embolization (PVE) alone or Combined Portal and Hepatic Vein Embolization (PVE/HVE) to increase future liver remnant volume and function before surgery.
1 visit for embolization procedure and follow-up visits until resectability assessment
Duration - Up to 5 years
Participants are monitored for overall survival and quality of life after treatment and potential surgery.
Periodic follow-up visits over 5 years for survival and quality of life assessments
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
Research Team
F
Fenna A van der Zijden, MSc Technical Medicine
S
Sinead James, MD
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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