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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06914648




Registration number
NCT06914648
Ethics application status
Date submitted
21/03/2025
Date registered
6/04/2025

Titles & IDs
Public title
The Dragon PLC Trial (DRAGON-PLC)
Scientific title
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.
Secondary ID [1] 0 0
NL87590.0681.24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Liver Cancer 0 0
Hepatocellular Carcinoma (HCC) 0 0
Cholangiocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Portal Vein Embolization
Treatment: Surgery - Hepatic Vein Embolization

Active comparator: Portal Vein Embolization (PVE) - control arm - Portal Vein Embolization (PVE) alone

Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional arm - Combined Portal and Hepatic Vein Embolization (PVE/HVE)


Treatment: Surgery: Portal Vein Embolization
Description: Portal Vein embolization with Glue by a transhepatic approach

Treatment: Surgery: Hepatic Vein Embolization
Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Resectability 3 weeks after embolisation
Timepoint [1] 0 0
3 weeks
Primary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Liver cirrhosis with a Child-Pugh score of B or C;
* Presence of portal hypertension;
* 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);
* Patients with hepatic malignancies other than iCCC, pCCC or HCC;
* PVE/HVE anatomically not feasible;
* Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.
* Unable to understand the study information, study instructions and give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2032
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
Namen
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Hasselt
Country [8] 0 0
Belgium
State/province [8] 0 0
Jette
Country [9] 0 0
Belgium
State/province [9] 0 0
Kortrijk
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Canada
State/province [11] 0 0
Montreal
Country [12] 0 0
Canada
State/province [12] 0 0
Ottawa
Country [13] 0 0
Netherlands
State/province [13] 0 0
Limburg
Country [14] 0 0
Netherlands
State/province [14] 0 0
Noord Holland
Country [15] 0 0
Netherlands
State/province [15] 0 0
Eindhoven
Country [16] 0 0
Netherlands
State/province [16] 0 0
Groningen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Leiden
Country [18] 0 0
Netherlands
State/province [18] 0 0
Utrecht

Funding & Sponsors
Primary sponsor type
Other
Name
Maastricht University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fenna A van der Zijden, MSc Technical Medicine
Address 0 0
Country 0 0
Phone 0 0
+31640911632
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06914648