DRAGON PLC: an international multicentre randomized controlled trial to compare combined portal and hepatic vein embolization with portal vein embolization alone in patients with primary liver cancers

Introduction: Patients with primary liver cancers (PLC) are often ineligible for liver resection because an inadequate future liver remnant (FLR) poses too high a risk of post-hepatectomy liver failure. FLR growth can be induced by portal vein embolization (PVE), the current standard. PVE combined with embolization of the hepatic veins (PVE/ HVE) is expected to increase resectability, degree of hypertrophy and kinetic growth rate of the FLR.
Aim: The aim of the DRAGON PLC RCT is to evaluate the superiority of PVE/HVE over PVE regarding overall survival and resectability in patients with PLC.
Methods: During 2.5 years, 358 patients with perihilar cholangiocarcinoma (pCCC), intrahepatic cholangiocarcinoma (iCCC) or hepatocellular carcinoma (HCC) requiring preoperative FLR regeneration will be randomized to PVE/ HVE or PVE (1:1, stratified by tumour type). Work instructions standardize the interventions. Clinical and imaging
data are collected 1, 3 and 6 weeks after PVE(/HVE), concerning resection, and during 5 years of follow-up. Split primary endpoints are defined as: FLR considered sufficient for resection 3 weeks after embolization and 5-year overall survival. FLR volume and function increase, quality of life and costs, among other secondary endpoints, are also assessed.
Results: The DRAGON PLC RCT has been granted funding by the Dutch Cancer Society, ZonMw and KCE, and is due to start accrual at the beginning of 2025. Nine Belgian centres will participate in the trial, with the CHU de Liège as the Belgian coordinating centre.
Conclusions: The effect of PVE/HVE on resectability and survival is expected to illuminate new treatment pathways, ensuring rapid, safe and cost-effective extended liver resections.