Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 20, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

December 30, 2027

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

Lenvatinib

"Participants will receive approximately six, 28-day cycles of lenvatinib (LENVIMA®, Eisai Inc., Woodcliff Lake, NJ). Lenvatinib will be administered at 12 mg orally once daily for patients with a body weight ≥60 kg and at 8 mg orally once daily for patients with a body weight of \<60 kg.~Administration of lenvatinib will occur at least 2 weeks before the first standard of care TACE procedure and study drug treatment will continue for 6 months. Lenvatinib will be held for 7 days before and 7 days after each TACE. Participants can receive up to 3 TACE procedures per protocol depending on their response and transplantation time."

PROCEDURE

Transcatheter Arterial Chemoembolization

Traditional standard of care: Transcatheter Arterial Chemoembolization (TACE) treatment for hepatocellular carcinoma. Chemotherapeutic drug-coated particles are inserted via a catheter into an artery that supplies blood to a tumor where the drug works to cut off blood supply to the tumor.

Trial Locations (1)

77030

Houston Methodist Research Institute, Houston

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

The Methodist Hospital Research Institute

OTHER