The Dragon PLC Trial (DRAGON-PLC)
Recruiting now · Not applicable
Conditions studied: Primary Liver Cancer, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06914648
- Run by
- Maastricht University
- People needed
- 358
- Starts
- 2025-04-01
- Expected to finish
- 2032-11-15
- Last updated by the study team
- 2025-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- CHU Liège — Liège, Liège, Belgium (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States
- UZ Brussel — Jette, Belgium
- Cleveland Clinic — Cleveland, Ohio, United States
- Monash Medical Center — Melbourne, Australia
- Medical University of Vienna — Vienna, State of Vienna, Austria
- Social Center South — Vienna, State of Vienna, Austria
- Erasmus Hospital — Brussels, Brussels Capital, Belgium
- UZ Antwerpen — Antwerp, Edegem, Belgium
- UZ Gent — Ghent, Gent, Belgium
- St. Joseph's Health Centre — Toronto, Ontario, Canada
- CHU-UCL Namur site Godinne (UCLouvain) — Yvoir, Namen, Belgium
- Cliniques Universitaires Saint Luc, UCLouvain — Brussels, Belgium
- Jessa Hospital — Hasselt, Belgium
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- AZ Groeninge Hospital Kortrijk — Kortrijk, Belgium
- Foothills Medical Center — Calgary, Alberta, Canada
- Vancouver General Hospital — Vancouver, British Columbia, Canada
- Queen Elizabeth II Health Sciences Center — Halifax, Nova Scotia, Canada
- Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada
- Kingston Health Sciences Centre — Kingston, Ontario, Canada
- London Health Sciences Centre — London, Ontario, Canada
- Rush University Medical Center — Chicago, Illinois, United States
- Sunnybrook Hospital — Toronto, Ontario, Canada
- Yale School of Medicine Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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