The Dragon PLC Trial (DRAGON-PLC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Liver cirrhosis with a Child-Pugh score of B or C;
Presence of portal hypertension;
Presence of cholangitis;
Pregnant women;
Trial design
Design model
Parallel
Treatments tested in this trial
Portal Vein Embolization
Procedure/SurgeryDescription: Portal Vein embolization with Glue by a transhepatic approach
Hepatic Vein Embolization
Procedure/SurgeryHepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Treatment groups
358 Participants
are divided into 2 treatment groupsGroup A: Portal Vein Embolization (PVE) - control armActive comparator 1 intervention
Group B: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Resectability 3 weeks after embolisation
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
Time frame
3 weeks2
Overall survival
survival data will be recorded up to 5-years
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov