| NCT ID | NCT06914648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University |
| Condition | Primary Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 358 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2032-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 358 participants in total. It began in 2025-04-01 with a primary completion date of 2032-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06914648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06914648 currently recruiting?
Yes, NCT06914648 is actively recruiting participants. Contact the research team at fenna.van.der.zijden@mumc.nl for enrollment information.
Where is the NCT06914648 trial being conducted?
This trial is being conducted at New Haven, United States, Chicago, United States, Rochester, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT06914648 clinical trial?
NCT06914648 is sponsored by Maastricht University. The trial plans to enroll 358 participants.
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