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Combining portal and hepatic vein embolization for liver cancer treatment

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.

Not applicable Interventional Maastricht University · NCT06914648

This study is testing if combining two types of vein treatments can help more people with liver cancer have surgery and live longer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment358 (estimated)
Ages18 Years and up
SexAll
SponsorMaastricht University Academic / other
Drugs / interventionschemotherapy
Locations55 sites (New Haven, Connecticut and 54 other locations)
Trial IDNCT06914648 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with primary liver cancer who require PVE due to insufficient future liver remnant volume.

Not a fit: Patients with liver cirrhosis classified as Child-Pugh score B or C, or those with significant comorbidities that prevent surgical intervention, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the number of patients who can undergo curative surgery for liver cancer, leading to improved survival rates.

How similar studies have performed: Other studies have shown promising results with similar embolization techniques, suggesting potential for success in this novel combined approach.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

New Haven, Connecticut and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Liver CancerHepatocellular CarcinomaCholangiocarcinomaPrimary liver cancerFuture Liver RemnantLiver regenerationPortal Vein EmbolizationHepatic Vein Embolization
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.