Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer (NCT02081755) | Clinical Trial Compass
By InvitationPhase 4
Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
United States336 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Screening Inclusion Criteria:
* Have a diagnosis of hepatocellular carcinoma (HCC) and high risk for HCC recurrence
* Able to provide written informed consent
* Male and female patients of any race, 18 years or older
* De novo recipients of a primary orthotopic liver transplant from a deceased or living donor
* Patients willing to comply with study requirements
* Women of child-bearing potential (WOCBP) must agree to use an effective method(s) of contraception during treatment and during the post treatment follow-up period
Screening Exclusion Criteria:
* Past or present malignancy within the last 5 years.
* Severe infection considered by the local site investigator to be unsafe for study participation.
* Use of other investigational drugs at the time of screening or within the last 30 days.
* Patients scheduled for a combined transplant (such as liver-kidney), or having a previous solid organ, bone marrow, or autologous islet cell transplant.
* Recipients of donor/recipient ABO incompatible grafts.
* Recipients of organs from human immunodeficiency virus (HIV) or HBsAg positive donors.
* Macrovascular tumor invasion.
* Proteinuria greater than 2 grams/24 hours.
* Conditions which can result in impaired absorption, distribution, metabolism or excretion of the study treatment.
* Patients with non-infectious pneumonitis.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first.