Status:
RECRUITING
The Dragon PLC Trial (DRAGON-PLC)
Lead Sponsor:
Maastricht University
Conditions:
Primary Liver Cancer
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Detailed Description
Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2032
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT06914648
Start Date
April 1 2025
End Date
November 15 2032
Last Update
May 15 2025
Active Locations (55)
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1
Yale School of Medicine Hospital
New Haven, Connecticut, United States, 06510
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065