Compares two liver vein blocking procedures in people with primary liver cancer
Tests combined portal and hepatic vein embolization in adults with liver or bile duct cancer.
Key facts
- Who runs it
- Maastricht University
- Where
- Basel, Lausanne, Lucerne, Winterthur, and Zurich, SwitzerlandSee the 6 sitesAlso in 11 other countries, 49 sites
- Trial code
- Registry title
- The Dragon PLC Trial (DRAGON-PLC)
- Status
- Recruiting
- People taking part
- 358 people, planned
- Started
- 1 Apr 2025
- Expected to end
- 15 Nov 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Portal Vein Embolization
- Hepatic Vein Embolization
- Record updated
- 15 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary liver cancer (hepatocellular carcinoma or cholangiocarcinoma) who need portal vein embolization because the part of the liver that would remain after surgery is too small.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Primary liver cancer (iCCC, pCCC or HCC) that needs portal vein embolization because the future liver remnant (FLR) volume is below 30%, 40% or 50% depending on liver function, or liver function on hepatobiliary scintigraphy (HEBIS) is below 2.7 %/min/m2. People with liver cirrhosis can join only up to Child-Pugh A5.
Main reasons for not taking part
- Liver cirrhosis with a Child-Pugh score of B or C
- Portal hypertension or cholangitis
- Pregnant women
- Cancer that cannot be removed by surgery because of other serious health problems
- Cancer spread outside the liver that cannot be removed or ablated
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you 18 years old or older?
- Are you planning to have, or have you had, an operation to remove part of your liver?
- Has a doctor told you that the part of your liver that would be left after surgery may be too small?
- Are you pregnant or breastfeeding?
Where in Switzerland
Also in 11 other countries, 49 sites
- Claraspital BaselBasel, SwitzerlandContact: O. Kollmar, Prof. (principal investigator)Not yet recruiting
- Universitätsspital BaselBasel, SwitzerlandContact: O. Kollmar, Prof. (principal investigator)Not yet recruiting
- Chuv, Lausanne University HospitalLausanne, SwitzerlandContact: E. Melloul, Dr. (principal investigator)Not yet recruiting
- Hirslanden Klinik St. AnnaLucerne, SwitzerlandContact: E. Schadde, Prof. (principal investigator)Not yet recruiting
- Cantonal Hospital WinterthurWinterthur, SwitzerlandContact: L.F. Grochola, Dr. (principal investigator)Not yet recruiting
- Hirslanden KlinikZurich, SwitzerlandContact: M. Schiesser, Prof. (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Portal Vein Embolization (PVE) - control armExisting treatment, for comparison
Portal Vein Embolization (PVE) alone
Treatment: Portal Vein Embolization
- Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional armTreatment being tested
Combined Portal and Hepatic Vein Embolization (PVE/HVE)
Treatment: Portal Vein Embolization and Hepatic Vein Embolization
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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.
- Plain-language title
- Compares two liver vein blocking procedures in people with primary liver cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06914648, who can take part
- Record updated
- 15 May 2025