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The Dragon PLC Trial (DRAGON-PLC)

Recruiting

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.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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.

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

About the study

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.

What is being tested

Portal Vein Embolization (procedure)
Hepatic Vein Embolization (procedure)

Sponsor: Maastricht University · Participants: 358 · Started: Apr 1, 2025

Contact the study team

Fenna A van der Zijden, MSc Technical Medicine · Phone: +31640911632
Sinead James, MD · Phone: +31 638463945

Official record on ClinicalTrials.gov — NCT06914648

Locations in the U.S.

Connecticut	Yale School of Medicine Hospital, New Haven (Not yet recruiting)
Illinois	Rush University Medical Center, Chicago (Not yet recruiting)
Minnesota	Mayo Clinic, Rochester (Not yet recruiting)
New York	Memorial Sloan Kettering Cancer Center, New York (Not yet recruiting)
Ohio	Cleveland Clinic, Cleveland (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.