The Dragon PLC Trial (DRAGON-PLC)

Launched by MAASTRICHT UNIVERSITY · Mar 31, 2025

Keywords

ClinConnect Summary

The DRAGON PLC Trial is studying a new treatment approach for patients with certain types of primary liver cancer, specifically hepatocellular carcinoma (HCC) and cholangiocarcinoma. The trial aims to find out if combining two procedures—portal vein embolization (PVE) and hepatic vein embolization (HVE)—can help more patients become eligible for surgery and improve their chances of survival compared to the standard PVE alone. Researchers want to see if this combination treatment leads to better liver growth, making it possible for more patients to have their tumors removed within three weeks.

To be eligible for the trial, participants must be at least 18 years old and diagnosed with the specified liver cancers, needing PVE due to a low volume of healthy liver tissue. However, people with certain liver conditions and those who can't fully understand the study or provide consent won't be included. Participants will either receive the standard PVE or the combined PVE and HVE treatment, and they'll have regular check-ups through imaging to see if their condition improves, along with follow-ups for up to five years to monitor their overall survival. The trial is not yet recruiting participants, so there will be more information available in the future.

Gender

ALL

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