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DRAGON-PLC Trial for Primary Liver Cancer

The DRAGON-PLC trial is studying a new approach for primary liver cancer (PLC), including hepatocellular carcinoma (HCC) and cholangiocarcinoma, that cannot be immediately removed by surgery. This study compares two procedures: standard portal vein embolization (PVE) alone, or PVE combined with hepatic vein embolization (HVE). PVE and HVE are procedures that block blood flow to parts of the liver to encourage the healthy part of the liver to grow, making surgery possible. The goal is to see if combining PVE and HVE helps more patients become eligible for surgery within 3 weeks and improves their overall survival over 5 years. You may be eligible if you have PLC and need PVE because your healthy liver volume is too small for surgery.

Study design
This interventional study plans to enroll 358 participants. It compares two different procedures for primary liver cancer.
What's involved
You would undergo either standard PVE or combined PVE and HVE. You would also have regular imaging to check if your liver can be resected (surgically removed).
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to 5 years after the procedure.

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NCT06914648

The Dragon PLC Trial (DRAGON-PLC)

Recruiting
NAAges 18+InterventionalTreatment
Maastricht University
~358 participants
Updated 2025-05-15 on ClinicalTrials.gov
What's tested:Portal Vein EmbolizationHepatic Vein Embolization

At a glance

Recruiting sites
1 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resectability 3 weeks after embolisation
Measured over 3 weeks
+1 more outcome measured

Conditions

Primary Liver Cancer
Hepatocellular Carcinoma (HCC)
Cholangiocarcinoma

Explore related trials

CholangiocarcinomaHepatocellular Carcinoma

Where it's being run

55 sites across 29 states
Ontario6
United Kingdom6
Switzerland5
Belgium4
Canada4
Germany3
Netherlands3
State of Vienna2

Who to contact

Fenna A van der Zijden, MSc Technical Medicine
[email protected]
+31640911632
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Resectability 3 weeks after embolisation3 weeks

    The FLR is considered sufficient for resection 3 weeks after embolisation. Definition resectable: Patients are deemed resectable if the FLR is ≥30% in normally functioning livers, ≥40% in livers with potentially impaired function (e.g. resulting from prior systemic therapy or bile duct colonization / transpapillary biliary drainage), or ≥50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR for any FLR volume, function on hepatobiliary scintigraphy is \> 2.7 %/min/m2

  • Overall survival5 years

    survival data will be recorded up to 5-years