Lenvatinib + TACE for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Maen Abdelrahim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The Methodist Hospital Research Institute

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will examine the effects of a six-month regimen of neoadjuvant lenvatinib in combination with transcatheter arterial chemoembolization (TACE) prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria. Clinical, outcomes, and exploratory data will be compared to a matched, retrospective cohort.

Research Team

Maen Abdelrahim, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for adults with advanced liver cancer (HCC) who haven't had previous cancer treatments, are on the liver transplant list, and can perform daily activities with little to no assistance. They must have well-managed hepatitis if present, good organ function, not be pregnant or breastfeeding, and agree to use effective contraception.

Inclusion Criteria

My organs and bone marrow are functioning well.

I am a man who can father children and will use condoms or other effective birth control.

I am an adult with liver cancer that has progressed beyond early stages.

Exclusion Criteria

I am not pregnant, breastfeeding, allergic to lenvatinib, and I agree to use contraception.

My high blood pressure is not controlled despite taking medication.

I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

Treatment Details

Interventions

• Lenvatinib (Tyrosine Kinase Inhibitor)
• Transcatheter Arterial Chemoembolization (Procedure)

Trial Overview The study tests a combination of Lenvatinib medication and TACE procedure over six months before a liver transplant in patients with large HCC tumors. It aims to compare these patients' outcomes against those from past records who didn't receive this treatment.

Participant Groups

Group I: Matched Historical Control Patients Experimental Treatment 1 Intervention

Historical controls will be liver transplant recipients matched on age, etiology of liver disease (viral vs. non-viral), listing tumor size, and number of TACE procedures to cases in the intervention group who receive a transplant.

Group II: Lenvatinib in Combination with TACE Prior to Liver Transplantation Experimental Treatment 2 Interventions

Regimen of six months neoadjuvant lenvatinib in combination with TACE prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Dr. John P. Cooke

The Methodist Hospital Research Institute

Chief Medical Officer since 2013

MD, PhD

Dr. Jenny Chang

The Methodist Hospital Research Institute

Chief Executive Officer

MBBChir from University of Cambridge, MHCM from Johns Hopkins University

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University