Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
Lenvatinib in Recurrent Hepatocellular Carcinoma After Liver Transplantation
Sponsor: Eisai Co., Ltd.
Terminated
Slow Accrual
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More terminations from Eisai Co., Ltd.
Other Recurrent Hepatocellular Carcinoma trials with similar outcome
A observational or N/A phase clinical study on Recurrent Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, this trial is terminated or withdrawn. The trial is conducted by Eisai Co., Ltd. and has accumulated 11 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
Apr 28, 2026 — Present [daily]
Terminated
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Apr 21, 2026 — Apr 28, 2026 [daily]
Terminated
Status: Recruiting → Terminated · Phase: PHASE2 → None
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Jan 2025 — Apr 2026 [monthly]
Recruiting PHASE2
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Sep 2024 — Jan 2025 [monthly]
Recruiting PHASE2
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE2
▶ Show 6 earlier versions
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE2
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Jul 2023 — Jul 2024 [monthly]
Recruiting PHASE2
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Jul 2022 — Jul 2023 [monthly]
Recruiting PHASE2
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May 2022 — Jul 2022 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Apr 2022 — May 2022 [monthly]
Not Yet Recruiting PHASE2
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Dec 2021 — Apr 2022 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility 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.
Contact Information
- Eisai Co., Ltd.
- Emory University
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .