The Dragon PLC Trial (DRAGON-PLC)

Condition(s) studied

Investigational drug(s) / intervention(s)

Portal Vein Embolization: Description: Portal Vein embolization with Glue by a transhepatic approach

Hepatic Vein Embolization: Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Study summary

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

Primary outcome measure(s)

• Resectability 3 weeks after embolisation — 3 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 survival — 5 years
  survival data will be recorded up to 5-years

Trial sites (55)

+ 15 more sites — see the full list on the official registry below.

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