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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.

Plain-language title generated from the registry record
Registry title: The Dragon PLC Trial (DRAGON-PLC)

Key facts

Where
Basel, Lausanne, Lucerne, Winterthur, and Zurich, SwitzerlandSee the 6 sites

Could this be for you?

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?

Source: NCT06914648, who can take part

Where in Switzerland

  • Claraspital BaselBasel, SwitzerlandNot yet recruiting
  • Universitätsspital BaselBasel, SwitzerlandNot yet recruiting
  • Chuv, Lausanne University HospitalLausanne, SwitzerlandNot yet recruiting
  • Hirslanden Klinik St. AnnaLucerne, SwitzerlandNot yet recruiting
  • Cantonal Hospital WinterthurWinterthur, SwitzerlandNot yet recruiting
  • Hirslanden KlinikZurich, SwitzerlandNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Maastricht University
Trial code
NCT06914648
Record updated
15 May 2025
Original description
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 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.

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.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06914648