Maastricht University
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.
Primary Liver Cancer
Hepatocellular Carcinoma (HCC)
Cholangiocarcinoma
Portal Vein Embolization
Hepatic Vein Embolization
NA
Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and \>70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver. This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs. Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 358 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| 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. |
| Actual Study Start Date : | 2025-04-01 |
| Estimated Primary Completion Date : | 2032-11-15 |
| Estimated Study Completion Date : | 2032-11-15 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
Yale School of Medicine Hospital
New Haven, Connecticut, United States, 06510
NOT YET RECRUITING
Rush University Medical Center
Chicago, Illinois, United States, 60612
NOT YET RECRUITING
Mayo Clinic
Rochester, Minnesota, United States, 55905
NOT YET RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
NOT YET RECRUITING
Cleveland Clinic
Cleveland, Ohio, United States, 44195
NOT YET RECRUITING
Monash Medical Center
Melbourne, Australia,
NOT YET RECRUITING
Medical University of Vienna
Vienna, Austria, 1090
NOT YET RECRUITING
Social Center South
Vienna, Austria, 1100
NOT YET RECRUITING
Erasmus Hospital
Brussels, Bruxelles, Belgium, 1070
NOT YET RECRUITING
UZ Antwerp
Antwerp, Edegem, Belgium, 2650
NOT YET RECRUITING
Chu-Kalam Namur Site Godin (Uklounwine)
Yvoir, Name, Belgium, 5530
NOT YET RECRUITING
Saint Luke university clinics, UClouvain
Brussels, Belgium, 1200
NOT YET RECRUITING
To Gent
Gent, Belgium, 9000
NOT YET RECRUITING
Jessa Hospital
Hasselt, Belgium, 3500
NOT YET RECRUITING
Already brussel
Throw, Belgium, 1090
NOT YET RECRUITING
AZ Groeninge Hospital Kortrijk
Kortrijk, Belgium, 8500
RECRUITING
CHU Liège
Liège, Belgium, 4000
NOT YET RECRUITING
Foothills Medical Center
Calgary, Alberta, Canada,
NOT YET RECRUITING
Vancouver General Hospital
Vancouver, British Columbia, Canada,
NOT YET RECRUITING
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada,
NOT YET RECRUITING
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada,
NOT YET RECRUITING
Kingston Health Sciences Centre
Kingston, Ontario, Canada,
NOT YET RECRUITING
London Health Sciences Centre
London, Ontario, Canada,
NOT YET RECRUITING
St. Joseph's Health Centre
Toronto, Ontario, Canada,
NOT YET RECRUITING
Sunnybrook Hospital
Toronto, Ontario, Canada,
NOT YET RECRUITING
University Health Network/TGH
Toronto, Ontario, Canada,
NOT YET RECRUITING
Sherbrooke University Hospital Center
Sherbrooke, Quebec, Canada,
NOT YET RECRUITING
University of Montreal hospital center
Montreal, Canada,
NOT YET RECRUITING
McGill University Health Centre, Montreal
Montreal, Canada,
NOT YET RECRUITING
L'hopital d'OTtawa
Ottawa, Canada,
NOT YET RECRUITING
Royal University Hospital
Saskatoon, Canada,
NOT YET RECRUITING
University Hospital Dresden
Dresden, Germany,
NOT YET RECRUITING
University Hospital Hanover
Hannover, Germany,
NOT YET RECRUITING
University Hospital Cologne
Köln, Germany,
NOT YET RECRUITING
San Raffaele Hospital
Milan, Italy,
NOT YET RECRUITING
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX
NOT YET RECRUITING
Amsterdam UMC, Location VUmc
Amsterdam, North Holland, Netherlands,
NOT YET RECRUITING
Maxima Medical Center
Eindhoven, Netherlands,
NOT YET RECRUITING
University Medical Center Groningen
Groningen, Netherlands,
NOT YET RECRUITING
Leiden University Medical Center
Leiden, Netherlands,
NOT YET RECRUITING
University Hospital Oslo
Oslo, Norway,
NOT YET RECRUITING
University Hospital Linköping
Linköping, Sweden,
NOT YET RECRUITING
Karolinska University Hospital Stockholm
Stockholm, Sweden,
NOT YET RECRUITING
Cantonal Hospital Winterthur
Winterthur, Zürich, Switzerland,
NOT YET RECRUITING
Claraspital Basel
Basel, Switzerland,
NOT YET RECRUITING
University Hospital Basel
Basel, Switzerland,
NOT YET RECRUITING
Chuv - Lausanne University Hospital
Lausanne, Switzerland,
NOT YET RECRUITING
Hirslanden Klinik St. Anna
Lucerne, Switzerland,
NOT YET RECRUITING
The Hirslanden clinic
Zürich, Switzerland,
NOT YET RECRUITING
Belfast Health and Social Care Trust
Belfast, United Kingdom,
NOT YET RECRUITING
Queen Elizabeth Hospital
Birmingham, United Kingdom,
NOT YET RECRUITING
Aintree University Hospital
Liverpool, United Kingdom,
NOT YET RECRUITING
Kings college Hospital
London, United Kingdom,
NOT YET RECRUITING
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom,
NOT YET RECRUITING
University Hospital Southampton
Southampton, United Kingdom,