The Dragon PLC Trial (DRAGON-PLC)

Description

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.

Conditions

Primary Liver Cancer, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma

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Study Overview

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Study Details

Study overview

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.

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.

The Dragon PLC Trial (DRAGON-PLC)

Condition
Primary Liver Cancer
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale School of Medicine Hospital, New Haven, Connecticut, United States, 06510

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Maastricht University,

Study Record Dates

2032-11-15