The DRAGON-PLC trial: An international multicentre randomised controlled trial to compare combined Portal and Hepatic Vein Embolisation (PVE/HVE) with PVE alone in patients with primary liver cancers.

The DRAGON-PLC trial: An international multicentre randomised controlled trial to compare combined Portal and Hepatic Vein Embolisation (PVE/HVE) with PVE alone in patients with primary liver cancers. - The DRAGON-PLC trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57347

Enrollment

Registered

2024-08-06

Start date

2025-07-16

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma / cholangiocarcinoma primary liver cancer liver cancer / bile duct cancer

Interventions

The study interventions consist of a combined Portal Vein and Hepatic Vein Embolisation (PVE/HVE) in the intervention group and PVE only in the control group. After the intervention, patients will h

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - PLC diagnosis, specifically intrahepatic cholangiocarcinoma (iCCC), perihilar cholangiocarcinoma (pCCC), and hepatocellulair carcinoma (HCC); - Requiring PVE due to an FLR volume is = 18 years; - Able to understand the trial and provide informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
A split primary endpoint will be evaluated: resectability and overall survival. * 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 > 2.67 %/min/m2 * 5-year overall survival	—

Measure

Time frame

A split primary endpoint will be evaluated: resectability and overall survival. * 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 > 2.67 %/min/m2 * 5-year overall survival

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Secondary

Measure	Time frame
Additional outcomes will be assessed in order to compare PVE/HVE to PVE embolisation. These endpoints entail several read-outs regarding liver growth, complications and 90-day survival after embolization and resection, clinical resection rates, composites of resectability and 90-day survival, QoL of the patient, costs, salvage procedures in case of insufficient FLR growth after embolization, recurrence and oncological interventions during follow-up. A detailed overview of all secondary endpoints is given in Section 4.	—

Measure

Time frame

Additional outcomes will be assessed in order to compare PVE/HVE to PVE embolisation. These endpoints entail several read-outs regarding liver growth, complications and 90-day survival after embolization and resection, clinical resection rates, composites of resectability and 90-day survival, QoL of the patient, costs, salvage procedures in case of insufficient FLR growth after embolization, recurrence and oncological interventions during follow-up. A detailed overview of all secondary endpoints is given in Section 4.

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Countries

Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Norway, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactF.A. Zijden

Maastricht Universitair Medisch Centrum +

fenna.van.der.zijden@mumc.nl+31640911632

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026