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mTOR inhibitor

Everolimus for Liver Cancer

Phase 4
Waitlist Available
Led By Goran Klintmalm, MD, PhD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of hepatocellular carcinoma (HCC) and high risk for HCC recurrence
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if a drug called Everolimus can help prevent liver cancer from coming back after a liver transplant for people with hepatocellular carcinoma.

Who is the study for?
This trial is for adults over 18 who've had a liver transplant due to hepatocellular carcinoma (HCC), are at high risk of cancer coming back, and can follow the study rules. Women able to have children must agree to use birth control during and after the study.
What is being tested?
The study compares Everolimus combined with Tacrolimus versus standard immunosuppressants like Mycophenolic acid/Mycophenolate Mofetil/Azathioprine with Tacrolimus in preventing HCC recurrence post-liver transplant. It's looking at how long patients stay disease-free, among other health outcomes.
What are the potential side effects?
Possible side effects include issues related to wound healing, hernia repair complications within a year, hepatic arterial thrombosis, changes in kidney function, acute cellular rejection, new-onset diabetes after transplant, hypertension (high blood pressure), and hyperlipidemia (high levels of fats in the blood).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have liver cancer with a high risk of it coming back.
Select...
I agree to use effective birth control during and after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107
20%
Hospitalization
20%
Immunosuppression held or modified
10%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Low Intensity Tacrolimus

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Everolimus and TacrolimusExperimental Treatment2 Interventions
Everolimus Dosing: 1.5 mg BID (3.0 mg/day) Tacrolimus Dosing: 0.05 mg/kg BID
Group II: Tacrolimus and Myfortic or CellCept or ImuranActive Control4 Interventions
Myfortic: 360 mg to 1080 mg BID OR CellCept: 500 mg to 1500 mg BID OR Imuran: 0.5mk/kg to 2mg/kg QD AND Tacrolimus Dosing: 0.05 mg/kg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Tacrolimus
2019
Completed Phase 4
~5510

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,089 Total Patients Enrolled
Goran Klintmalm, MD, PhDPrincipal InvestigatorBaylor Health Care System
~29 spots leftby Nov 2025
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