Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-02 @ 7:00 AM
Study NCT ID:
NCT05103904
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2021-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Lenvatinib in Recurrent Hepatocellular Carcinoma After Liver Transplantation
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-07757 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| Winship5381-21 | OTHER | Emory University Hospital/Winship Cancer Institute | View | |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |