At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Portal Vein Embolization (procedure), Hepatic Vein Embolization (procedure)
- How long the study runs
- Study runs about 91 months (dates as stated)
- About the drug or intervention
- Portal Vein Embolization — procedure: Description: Portal Vein embolization with Glue by a transhepatic approach · Hepatic Vein Embolization — procedure: Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Maastricht University, is looking at adults with primary liver cancer, including hepatocellular carcinoma (HCC, a cancer that starts in the liver) and cholangiocarcinoma (bile duct cancer). It is for people who need a procedure called portal vein embolisation (PVE, blocking a vein in the liver to help the remaining part grow) before surgery. The full aims and treatments of the trial are Not stated — ask the trial team.
Who can take part
- Adults aged 18 or over
- Diagnosed with primary liver cancer, specifically certain types of bile duct cancer (inside or outside the liver) or hepatocellular carcinoma (HCC)
- Need portal vein embolisation (PVE, blocking a vein so the remaining liver grows) because the future liver remnant (the part left after surgery) is too small — the size needed depends on how well the liver is working
- Able to understand the trial and agree to take part
Who may not be able to
- Severe scarring of the liver (cirrhosis) with a Child-Pugh score of B or C
- High blood pressure in the liver's veins (portal hypertension)
- An infection of the bile tubes (cholangitis)
- People who are pregnant
- Women who have not been through the menopause and cannot or will not use contraception (specifically long-acting or hormonal contraception)
- People who cannot have surgery because of other health problems, as decided by the local medical team
- Liver cancers other than the types listed above
- People for whom the PVE or HVE procedure is not possible due to the liver's anatomy
- Cancer that has spread outside the liver and cannot be removed or destroyed
- People unable to understand the study information or give informed consent
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 358
- Started
- 2025-04-01
- Last checked
- 2025-02
Plain English Summary
What is this study?
- • Testing a new treatment for primary liver cancer
- • NA - 358 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with primary liver cancer
Where?
- • Belfast - Belfast Health and Social Care Trust
- • Birmingham - Queen Elizabeth Hospital
- • Liverpool - Aintree University Hospital
- • London - Kings college Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓PLC diagnosis, specifically iCCC, pCCC, and HCC;
- ✓Age ≥ 18 years;
- ✓Able to understand the trial and provide agreement to take part.
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (6 UK sites)
Belfast Health and Social Care Trust
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Kings college Hospital
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
How to Get in Touch
Fenna A van der Zijden, MSc Technical Medicine
Sponsor contactCONTACT
Sinead James, MD
Sponsor contactCONTACT