Combining portal and hepatic vein embolization for liver cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DRAGON PLC clinical trial investigates the effectiveness of combining portal vein embolization (PVE) with hepatic vein embolization (HVE) to improve surgical resectability and overall survival in patients with initially unresectable primary liver cancer, specifically hepatocellular carcinoma and cholangiocarcinoma. Participants will be randomly assigned to receive either standard PVE or the combined approach, with regular imaging to assess liver resectability and monitoring for survival outcomes over five years. The study aims to enhance liver hypertrophy and increase the number of patients eligible for surgical resection, ultimately improving their quality of life and survival rates.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Liège
  Liège, Liège, Belgium Recruiting
• Yale School of Medicine Hospital
  New Haven, Connecticut, United States Not yet recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Not yet recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Not yet recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Not yet recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Not yet recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Fenna A van der Zijden, MSc Technical Medicine
• Email: fenna.van.der.zijden@mumc.nl
• Phone: +31640911632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.