Clinical Trial 24388

• Overview

  Study Title:

  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

  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.

  Objective:

  Primary Objectives * To investigate the effect of combined PVE/HVE compared to PVE alone on the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year overall survival. Secondary Objectives * Biliary drainage type * Repeat drainage/re-intervention * Rate of cholangitis (according to Tokyo guidelines) * Time from biliary drainage to embolisation * Weekly kinetic growth rate and volume of the FLR (efficacy assessment) * FLR function increase (Hepatobiliary scintigraphy, MRI-function) * The success rate of IR procedure (embolisation) performed as scheduled * Time to sufficient FLR volume * Salvage procedures after PVE or combined PVE/HVE * Post-embolisation complications prior to surgery * Time from intervention to resection * Clinical resectability * Operation time * Intraoperative complications * Intraoperative blood loss * Liver inflammation, fibrosis and cirrhosis at histology * Cancer type and mutations at histology * Number of postoperative complications/AE until 90 days post-surgery * Rate of PHLF * Mortality at 90 days * Radiological resectability and 90-day survival * Composite of clinical resectability and 90-day survival. * Survival at 3 years * Recurrence rate * Progression-free survival at 3 years * Recurrence location * Number and type of oncological interventions (for example repeat resections, ablations, selective internal radiation therapy (SIRT), Systemic therapy, etcetera) during survival * Reason for oncological intervention or best supportive care for all recurrences within 5 years * Cause of death * Quality of life (QoL) * Costs

• Inclusion Criteria

  Inclusion Criteria:
  • PLC diagnosis, specifically iCCC, pCCC, and HCC;
  • Requiring PVE due to an FLR volume is > Able to understand the trial and provide informed consent.
  • Other criteria may apply

• 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
  • Other exclusions may apply

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