The Dragon PLC Trial (DRAGON-PLC)

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Portal Vein Embolization
  Description: Portal Vein embolization with Glue by a transhepatic approach
• Процедура Hepatic Vein Embolization
  Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Первичные конечные точки

• Resectability 3 weeks after embolisation [Срок оценки: 3 weeks]
• Overall survival [Срок оценки: 5 years]

Критерии участия

Критерии включения

• PLC diagnosis, specifically iCCC, pCCC, and HCC;
• 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;
• Age ≥ 18 years;
• Able to understand the trial and provide informed consent.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 14 центров

• Foothills Medical Center — Calgary
• Vancouver General Hospital — Vancouver
• Queen Elizabeth II Health Sciences Center — Halifax
• Juravinski Hospital and Cancer Centre — Hamilton
• Kingston Health Sciences Centre — Kingston
• London Health Sciences Centre — London
• St. Joseph's Health Centre — Toronto
• Sunnybrook Hospital — Toronto
• … и ещё 6 центров

Бельгия · 9 центров

• Erasmus Hospital — Brussels
• UZ Antwerpen — Antwerp
• UZ Gent — Ghent
• CHU Liège — Liège
• CHU-UCL Namur site Godinne (UCLouvain) — Yvoir
• Cliniques Universitaires Saint Luc, UCLouvain — Brussels
• Jessa Hospital — Hasselt
• UZ Brussel — Jette
• … и ещё 1 центр

Швейцария · 6 центров

• Cantonal Hospital Winterthur — Winterthur
• Claraspital Basel — Basel
• Universitätsspital Basel — Basel
• CHUV - Lausanne University Hospital — Lausanne
• Hirslanden Klinik St. Anna — Lucerne
• Hirslanden Klinik — Zurich

Великобритания · 6 центров

• Belfast Health and Social Care Trust — Belfast
• Queen Elizabeth Hospital — Birmingham
• Aintree University Hospital — Liverpool
• Kings college Hospital — London
• Oxford University Hospitals NHS Foundation Trust — Oxford
• University Hospital Southampton — Southampton

США · 5 центров

• Yale School of Medicine Hospital — New Haven
• Rush University Medical Center — Chicago
• Mayo Clinic — Rochester
• Memorial Sloan Kettering Cancer Center — New York
• Cleveland Clinic — Cleveland

Нидерланды · 5 центров

• Maastricht Universitair Medisch Centrum+ — Maastricht
• Amsterdam UMC, location VUMC — Amsterdam
• Maxima Medisch Centrum — Eindhoven
• Universitair Medisch Centrum Groningen — Groningen
• Leiden Universitair Medisch Centrum — Leiden

Германия · 3 центра

• Universitätklinikum Köln — Cologne
• Universitätklinikum Dresden — Dresden
• Universitätklinikum Hannover — Hanover

Австрия · 2 центра

• Medical University of Vienna — Vienna
• Social Center South — Vienna

Швеция · 2 центра

• University Hospital Linköping — Linköping
• Karolinska University Hospital Stockholm — Stockholm

Австралия · 1 центр

• Monash Medical Center — Melbourne

Италия · 1 центр

• Ospedale San Raffaele — Milan

Норвегия · 1 центр

• University Hospital Oslo — Oslo

Идентификаторы

NCT: NCT06914648 · NL87590.0681.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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