RecruitingNAINTERVENTIONAL

The Dragon PLC Trial (DRAGON-PLC)

This study, called DRAGON-PLC, is for people with primary liver cancer, specifically hepatocellular carcinoma (HCC) or cholangiocarcinoma, who can't have surgery right away. Normally, a procedure called Portal Vein Embolization (PVE) helps make the liver ready for surgery. This study wants to find out if adding another procedure, Hepatic Vein Embolization (HVE), to PVE is even better. The main goals are to see if the combined approach allows more people to have surgery within three weeks and helps them live longer. Participants will receive either the standard PVE or the new combined PVE and HVE, and their progress will be watched for up to five years.

At a glance

Status

Recruiting

Phase

Sponsor

Maastricht University

Enrolment target

358

Start

01 Apr 2025

Estimated completion

15 Nov 2032

Primary Liver Cancer Hepatocellular Carcinoma (HCC)Cholangiocarcinoma

What is this study about?

Primary liver cancer can be a very serious illness, and often the best chance for a cure is surgery to remove the tumour. Sadly, many people are diagnosed when their cancer is quite advanced, and surgery isn't immediately possible for over 70% of them. One common reason for this is that removing the cancer might leave too little healthy liver behind, which could lead to severe liver problems after the operation.

Doctors have developed ways to help the healthy part of the liver grow bigger before surgery. The usual method is called Portal Vein Embolization (PVE). This procedure encourages the healthy part of the liver to grow, making it safer to remove the cancerous part. However, PVE doesn't work well enough for about a quarter of patients, meaning they still can't have the surgery. This study is testing a promising new approach that combines PVE with another procedure called Hepatic Vein Embolization (HVE).

The DRAGON-PLC study aims to see if combining PVE and HVE can help more people with primary liver cancer prepare for surgery successfully. The researchers want to know if this new combined treatment leads to a healthier, larger liver section faster, allowing more patients to have surgery. They will also track how long patients live after treatment, hoping to show that this new method can improve long-term survival compared to PVE alone. By making surgery an option for more people, this study hopes to improve quality of life and survival for those affected by these challenging cancers.

Key takeaways

This study evaluates two ways to prepare the liver for cancer surgery.
It compares a standard procedure (PVE) with a new combined one (PVE + HVE).
The main goals are to increase surgical eligibility and improve long-term survival.
Suitable for people with certain primary liver cancers (HCC, cholangiocarcinoma).
Participation involves treatment, regular scans, and up to 5 years of follow-up.

Who may be eligible?

This study is looking for adults aged 18 and over who have specific types of primary liver cancer called hepatocellular carcinoma (HCC) or cholangiocarcinoma. To be considered, your liver cancer must be the type that could potentially be removed by surgery, but currently, your liver isn't quite ready for the operation because the remaining healthy part would be too small. Your doctor will have checked this using scans or other tests.

There are also some conditions that would prevent you from joining. For example, if you have severe scarring of the liver (cirrhosis) or very high blood pressure in the liver (portal hypertension), or certain infections like cholangitis, you wouldn't be able to participate. Also, if your cancer has spread outside the liver or if you have other serious health problems that would make surgery too risky, this study wouldn't be right for you. Women who are pregnant or planning to become pregnant during the study would also not be able to participate unless they are using effective contraception.

Basically, the study is for people whose main barrier to life-saving liver surgery is the size of their healthy liver, and who are otherwise fit enough for treatment.

Quick self-check

I am 18 years old or older.
I have been diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma.
My doctors have said my liver is not quite ready for surgery yet because the healthy part is too small.
I do not have severe liver scarring (cirrhosis grade B or C) or cholangitis.
My cancer has not spread to other parts of my body that cannot be removed.
I am not pregnant and, if able to become pregnant, I am willing to use effective contraception.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you will be randomly assigned to receive one of two treatments: either the standard Portal Vein Embolization (PVE) or the new combined treatment of PVE and Hepatic Vein Embolization (HVE). You won't get to choose which one you receive, but both aim to help your liver grow.

After your treatment, you will have regular imaging scans, like CT or MRI, to check how well your liver is growing and if it's becoming suitable for surgery. The doctors will monitor your health and how you're doing for up to five years after your initial treatment. This long follow-up helps them understand the long-term benefits of each treatment. Throughout this period, you will have scheduled appointments and check-ups related to your cancer care.

Potential risks and benefits

Participating in this study might offer the potential benefit of allowing you to have life-saving surgery for your liver cancer, which might not otherwise be possible. If the new combined treatment proves more effective, it could offer a better chance of successful surgery and longer survival. However, as with any medical procedure, there are potential risks, such as side effects from the embolization procedures, including pain, fever, or more serious but less common complications. Your doctor will discuss all specific risks with you. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (55)

Yale School of Medicine Hospital
New Haven, United States· Not yet recruiting
Rush University Medical Center
Chicago, United States· Not yet recruiting
Mayo Clinic
Rochester, United States· Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, United States· Not yet recruiting
Cleveland Clinic
Cleveland, United States· Not yet recruiting
Monash Medical Center
Melbourne, Australia· Not yet recruiting
Medical University of Vienna
Vienna, Austria· Not yet recruiting
Social Center South
Vienna, Austria· Not yet recruiting
Erasmus Hospital
Brussels, Belgium· Not yet recruiting
UZ Antwerpen
Antwerp, Belgium· Not yet recruiting
UZ Gent
Ghent, Belgium· Not yet recruiting
CHU Liège
Liège, Belgium· Recruiting

+43 more sites — see the official record for the full list.

Common questions

What is 'embolization'?

Embolization is a procedure where doctors block off blood vessels that feed the cancerous part of your liver. This encourages the healthy part of your liver to grow bigger and stronger before surgery.

What is the difference between PVE and HVE?

PVE (Portal Vein Embolization) blocks a main blood vessel to part of the liver. HVE (Hepatic Vein Embolization) blocks another type of blood vessel. The study is comparing PVE alone with PVE plus HVE, to see if combining them helps the liver grow more effectively.

Will I definitely get surgery if I join this study?

The goal of these treatments is to make you eligible for surgery. While the study aims to increase the number of people who can have surgery, it cannot guarantee that surgery will be possible for everyone.

How long will I be followed up in this study?

You will be monitored for your health and treatment outcomes for up to five years, even if you have surgery sooner. This helps researchers understand the long-term effects of the treatments.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.

How to find out more

Fenna A van der Zijden, MSc Technical Medicine

fenna.van.der.zijden@mumc.nl +31640911632 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.