NCT05103904

Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant

Lenvatinib in Recurrent Hepatocellular Carcinoma After Liver Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 transplantation is a potentially curative treatment option for HCC, however, up to 20% of patients develop recurrent disease after liver transplantation 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 HCC after liver transplantation, so there is no established therapy for these patients. This phase II trial evaluates lenvatinib for this purpose.

Detailed description

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 cells and biomarkers. OUTLINE: Patients receive lenvatinib orally (PO) once daily (QD). Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the protocol therapy. After completion of study treatment, patients are followed for 30 days and then every 90 days until death or 2 years from registration.

Conditions

• Recurrent Hepatocellular Carcinoma
• Stage III Hepatocellular Carcinoma AJCC V8
• Stage IIIA Hepatocellular Carcinoma AJCC V8
• Stage IIIB Hepatocellular Carcinoma AJCC V8
• Stage IV Hepatocellular Carcinoma AJCC V8
• Stage IVA Hepatocellular Carcinoma AJCC V8
• Stage IVB Hepatocellular Carcinoma AJCC V8
• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenvatinib	Given PO

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-11-04
• Completion: 2026-11-04
• First posted: 2021-11-02
• Last updated: 2024-12-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study