This study is a prospective Phase IV study to determine if the use of Everolimus results
in lower liver tumor recurrence and improved patient and graft survival after liver
transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be
Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic
acid/Mycophenolate Mofetil/Azathioprine. Primary outcomes data is disease free survival
(the time from randomization to HCC recurrence or death). Secondary outcomes are rate of
recurrence of Hepatitis C, problems related to wound healing, hernia repair within the
first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection,
post-transplant diabetes, hypertension, and hyperlipidemia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02081755.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Name Not Available
The study population will consist of approximately 336 patients (224 Everolimus and
Tacrolimus and 112 Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil/Azathioprine).
Initial screening criteria will include the presence of hepatocellular carcinoma in
patients 18 years or older who are candidates to receive a primary orthotopic liver
transplant (from deceased or living donor). Within 7 - 12 days post-transplant, patients
will be re-evaluated for eligibility for randomization. The criteria include:
pre-transplant imaging that shows HCC disease exceeding Milan criteria; pathology review
for tumor burden and/or presence of microvascular invasion; AFP >200IU/mL; pre-transplant
ablation or resection with HCC recurrence; progression or new tumors; evaluation to rule
out any hepatic vessel complication.
Subjects will remain in study treatment until Month 12 at which time the subject and
investigator will determine the preferred immunosuppressive regimen. Subjects will be
followed for an additional 24 months for outcome data as described above.
Lead OrganizationBaylor University Medical Center
