NCT02081755

Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer

A 36 Month Multi-center, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus Dosing: 1.5 mg BID (3.0 mg/day) for 12 months
DRUG	Tacrolimus	Tacrolimus Dosing: 0.05 mg/kg BID for 12 months
DRUG	Myfortic	Myfortic®: 360 mg to 1080 mg BID for 12 months
DRUG	CellCept	CellCept: 500 mg to 1500 mg BID for 12 months
DRUG	Imuran	0.5 mg/kg to 2 mg/kg QD for 12 months

Timeline

• Start date: 2014-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2014-03-07
• Last updated: 2026-01-27

Locations

9 sites across 1 country: United States