The Dragon PLC Trial (DRAGON-PLC)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Yale School of Medicine Hospital, New Haven, Connecticut, United States
• Rush University Medical Center, Chicago, Illinois, United States
• Mayo Clinic, Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center, New York, New York, United States
• 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
• CHU Liège, Liège, Liège, Belgium

+ 43 more sites.

Who to contact

Fenna A van der Zijden, MSc Technical Medicine · +31640911632 · fenna.van.der.zijden@mumc.nl

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06914648.