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mTOR inhibitor

Everolimus for Hepatocellular Carcinoma

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 through month 36

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and through month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first.

Secondary outcome measures

Acute cellular rejection

Hepatic arterial thrombosis

Hepatitis C recurrence rate

+7 more

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%

Study treatment Arm

Standard of Care

Low Intensity Tacrolimus

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

2011

Completed Phase 4

~4740

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,085 Total Patients Enrolled

1 Trials studying Hepatocellular Carcinoma

40 Patients Enrolled for Hepatocellular Carcinoma

Goran Klintmalm, MD, PhDPrincipal InvestigatorBaylor Health Care System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the current patient cohort for this medical experiment?

"At the moment, this particular medical trial is not admitting patients. Initially posted on March 1st 2014 and last updated July 19th 2022, it does not currently have any open positions. Nevertheless, there are 2599 other clinical trials for carcinoma hepatocellular and 307 for Everolimus that require participants at this time."

Answered by AI

Is this research actively taking in participants?

"Unfortunately, this research is not accepting new patients at the moment. It was initially posted on March 1st 2014 and most recently updated on July 19th 2022. There are 2599 trials recruiting for carcinoma, hepatocellular related cases as well as 307 studies involving Everolimus that are actively seeking participants."

Answered by AI

What prior investigations have been undertaken featuring Everolimus?

"Currently, the research of Everolimus is being conducted on 307 trials. Of these studies, 42 are in Phase 3 and 5311 sites around the world are participating in this investigation. Not surprisingly, a large majority of them (307) stem from Philadelphia, Pennsylvania."

Answered by AI

In what parts of North America is this research trial being conducted?

"Patients seeking to participate in this trial may do so at the University of Kansas Medical Center, Washington University School of Medicine, Mayo Clinic and 9 other medical sites."

Answered by AI

In what medical cases is Everolimus most commonly prescribed?

"Everolimus is widely employed to manage difficult-to-treat advanced renal cell carcinoma, as well as dermatitis, atopic issues, multiple sclerosis and lupus nephritis."

Answered by AI