No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
358 (estimated)
Sponsor
Maastricht University · Other
Who this trial is looking for
This trial is looking for patients with certain types of liver cancer who may need a specific procedure. Participants will receive treatment and undergo regular checks on their liver health for up to 5 years.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with liver cancer.
I need portal vein embolization because my liver function is not adequate.
I am at least 18 years old.
I can understand the trial and give my consent.
You may not be able to join if
I have liver cirrhosis with a Child-Pugh score of B or C.
I have portal hypertension.
I have cholangitis.
I am pregnant.
I am a premenopausal female unable to commit to contraception.
I have other liver cancers besides the specified types.
My anatomy makes the procedures impossible.
I have extrahepatic metastatic disease that can't be treated.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 th…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 bil…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
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