RecruitingNot Applicable

The Dragon PLC Trial (DRAGON-PLC)

United States358 participantsStarted 2025-04-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Resectability 3 weeks after embolisation

Timeframe: 3 weeks

Overall survival

Timeframe: 5 years

Trial details

NCT IDNCT06914648

SponsorMaastricht University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-11-15

Contact for this trial

Fenna A van der Zijden, MSc Technical Medicine

+31640911632 fenna.van.der.zijden@mumc.nl