Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma after Liver Transplant

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma	NCT ID:	NCT05103904
Trial Phases:	Phase II	Protocol IDs:	Winship5381-21 (primary) NCI-2021-07757 STUDY00003060
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05103904

Summary

This phase II trial evaluates lenvatinib for the treatment of hepatocellular carcinoma (HCC) that has come back (recurrent) after a liver transplant. HCC is a cancer of the liver and is the second leading cause of cancer-related deaths in the world. Liver transplants are a curative option for HCC, however, up to 20% of patients develop recurrent disease and prognosis remains poor. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Systemic treatments for HCC have not been studied in patients with recurrent disease after liver transplantation, so there is no established therapy for these patients. This phase II trial evaluates lenvatinib for this purpose.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate anti-tumor activity of the lenvatinib by assessing the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of lenvatinib in patients with recurrent HCC after liver transplantation.
II. To evaluate the anti-tumor activity of the lenvatinib by assessing progression-free survival (PFS) and overall survival (OS) and duration of response.

TERTIARY/EXPLORATORY OBJECTIVE:
I. To assess the effects of the lenvatinib on circulating tumor deoxyribonucleic acid (DNA) and biomarkers.

OUTLINE:
Patients receive lenvatinib orally (PO) once daily (QD). Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal. Patients also undergo blood sample collection, computed tomography (CT) and magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed for 30 days and then every 90 days until death or 2 years from registration.

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