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The Dragon PLC Trial (DRAGON-PLC)

NCT06914648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Portal Vein Embolization

Description: Portal Vein embolization with Glue by a transhepatic approach

PROCEDURE

Hepatic Vein Embolization

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

Sponsors & Collaborators

  • Maastricht University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2032-11-15
Completion
2032-11-15

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914648 on ClinicalTrials.gov