NCT05103904

Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant

Recruiting now Phase 2 Last updated 27 December 2024

What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Hepatocellular Carcinoma in 19 participants. Currently enrolling.

Timeline

19 April 2022

Primary endpoint
4 November 2025

4 November 2026

Quick facts

Lead sponsor	Emory University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	19 April 2022
Primary completion	4 November 2025
Estimated completion	4 November 2026
Sites	3 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

• Recurrent Hepatocellular Carcinoma — all drugs for Recurrent Hepatocellular Carcinoma →
• Stage III Hepatocellular Carcinoma AJCC V8 — all drugs for Stage III Hepatocellular Carcinoma AJCC V8 →
• Stage IIIA Hepatocellular Carcinoma AJCC V8 — all drugs for Stage IIIA Hepatocellular Carcinoma AJCC V8 →
• Stage IIIB Hepatocellular Carcinoma AJCC V8 — all drugs for Stage IIIB Hepatocellular Carcinoma AJCC V8 →

Sponsor

Emory University

Who can join

18 and older, any sex, with Recurrent Hepatocellular Carcinoma or Stage III Hepatocellular Carcinoma AJCC V8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomarkers for diagnosis and therapeutic options in hepatocellular carcinoma.
   Chan YT, Zhang C, Wu J, Lu P, et al · · 2024 · cited 158× · PMID 39242496 · DOI 10.1186/s12943-024-02101-z
2. Frontline therapy for advanced hepatocellular carcinoma: an update.
   Akce M, El-Rayes BF, Bekaii-Saab TS. · · 2022 · cited 22× · PMID 35432597 · DOI 10.1177/17562848221086126
3. Application and Resistance Mechanisms of Lenvatinib in Patients with Advanced Hepatocellular Carcinoma.
   Tao M, Han J, Shi J, Liao H, et al · · 2023 · cited 14× · PMID 37457652 · DOI 10.2147/jhc.s411806
4. Combining local regional therapy and systemic therapy: Expected changes in the treatment landscape of recurrent hepatocellular carcinoma.
   Liang J, Bai Y, Ha FS, Luo Y, et al · · 2023 · cited 11× · PMID 36684055 · DOI 10.4251/wjgo.v15.i1.1
5. Small-molecule-based targeted therapy in liver cancer.
   Ming Y, Gong Y, Fu X, Ouyang X, et al · · 2024 · cited 6× · PMID 39113358 · DOI 10.1016/j.ymthe.2024.08.001
6. Insights in Molecular Therapies for Hepatocellular Carcinoma.
   Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
7. Systemic Treatment for Hepatocellular Carcinoma Recurrence After Liver Transplantation.
   Mazzarelli C, Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest Group, Berardi F, Bonfichi A, et al · · 2026 · PMID 41892169 · DOI 10.3390/curroncol33030141
8. [Chinese expert guidance on overall application of lenvatinib in hepatocellular carcinoma].
   Yang XR, Sun HC, Xie Q, Zhang WG, et al · · 2023 · PMID 38016765 · DOI 10.3760/cma.j.cn115610-20230201-00035-1