RECRUITING

The Dragon PLC Trial (DRAGON-PLC)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The DRAGON PLC Trial - An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) With PVE Alone in Primary Liver Cancers.

Quick Facts

Study Start:2025-04-01
Study Completion:2032-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06914648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PLC diagnosis, specifically iCCC, pCCC, and HCC;
  2. * Requiring PVE due to an FLR volume is \<30% in normally functioning livers, \<40% in livers with potentially impaired function e.g. resulting from prior systemic therapy induction or bile duct colonization / transpapillary biliary drainage, or \<50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR function on hepatobiliary scintigraphy (HEBIS) is \< 2.7 %/min/m2;
  3. * Age ≥ 18 years;
  4. * Able to understand the trial and provide informed consent.
  1. * Liver cirrhosis with a Child-Pugh score of B or C;
  2. * Presence of portal hypertension;
  3. * Presence of cholangitis;
  4. * Pregnant women;
  5. * Premenopausal females not able/willing to commit to contraception (specifically long-acting reversible contraception or hormonal contraception);
  6. * Patients unresectable due to prohibitive comorbidities (decision made by local multidisciplinary team);
  7. * Patients with hepatic malignancies other than iCCC, pCCC or HCC;
  8. * PVE/HVE anatomically not feasible;
  9. * Any patient with non-resectable or non-ablatable extrahepatic metastatic disease.
  10. * Unable to understand the study information, study instructions and give informed consent

Contacts and Locations

Study Contact

Fenna A van der Zijden, MSc Technical Medicine
CONTACT
+31640911632
fenna.van.der.zijden@mumc.nl
Sinead James, MD
CONTACT
+31 638463945
sinead.james@mumc.nl

Study Locations (Sites)

Yale School of Medicine Hospital
New Haven, Connecticut, 06510
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Maastricht University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2032-11-15

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2032-11-15

Terms related to this study

Keywords Provided by Researchers

  • Primary liver cancer
  • Future Liver Remnant
  • Liver regeneration
  • Portal Vein Embolization (PVE)
  • Hepatic Vein Embolization (HVE)

Additional Relevant MeSH Terms

  • Primary Liver Cancer
  • Hepatocellular Carcinoma (HCC)
  • Cholangiocarcinoma