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NCT05103904 · ClinicalTrials.gov registry record · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 3
- Study locations
NCT05103904: Recruiting Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Emory University.
NCT05103904 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 19 participants, below the 58-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05103904, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor measurements are performed every 8 weeks. ORR will be calculated as a proportion (complete responses + partial responses / total patients) along with a 95% confidence interval (CI) using the Clopper-Pearson method. Chi-square tests or Fisher's exact tests will be used to compare the efficacy in term of response rate across different groups stratified by biomarkers or other factors, respectively.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Lenvatinib
Study Locations (3)
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Arizona - Scottsdale
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2026-11-04 |
| Phase | Phase 2 |
What NCT05103904 shows while recruiting
NCT05103904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 58-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (67% lower).
The record links to 8 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT05103904 reports a single indexed study location in Alabama, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT05103904 about?
NCT05103904 is a clinical study titled "Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant". 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 tr...
What is the current status of trial NCT05103904?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2022-04-19. Estimated completion is 2026-11-04.
What conditions does trial NCT05103904 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IVA Hepatocellular Carcinoma AJCC V8.
What interventions are being tested in trial NCT05103904?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05103904?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05103904 being conducted?
This trial has 3 study locations across Alabama, Arizona, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Hepatocellular Carcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05103904's enrollment target sits among peer trials
19 12th of 14 higher than 3 of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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