OncoMatch/Clinical Trials/NCT05103904
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
Is NCT05103904 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lenvatinib for recurrent hepatocellular carcinoma.
Treatment: Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage III, IIIA, IIIB, IV, IVA, IVB (AJCC V8)
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: orthotopic liver transplant — curative intent
Prior orthotropic liver transplantation for curative intent
Cannot have received: lenvatinib
Prior systemic therapy with lenvatinib or another Food and Drug Administration (FDA) approved systemic therapy for hepatocellular carcinoma in the post-transplant setting.
Cannot have received: systemic therapy for hepatocellular carcinoma in the post-transplant setting
Prior systemic therapy with lenvatinib or another Food and Drug Administration (FDA) approved systemic therapy for hepatocellular carcinoma in the post-transplant setting.
Lab requirements
Blood counts
Hemoglobin >= 8.0 g/dl; ANC >= 1,500/mcL; Platelets >= 75,000/mcL
Kidney function
Serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN; Urinary protein <= 1+ on dipstick or < 1 g/24 hours
Liver function
Child Pugh class A; Total bilirubin <= 3x ULN; AST/ALT <= 5x ULN; Albumin >= 2.8 g/dL; INR <= 2.3
Cardiac function
NYHA class 2B or better; QTc interval <= 480 ms; No significant cardiovascular impairment (no CHF > NYHA II, unstable angina, MI or stroke within 6 months, or cardiac arrhythmia requiring medical treatment at screening)
Child Pugh class A; Hemoglobin >= 8.0 g/dl; ANC >= 1,500/mcL; Platelets >= 75,000/mcL; INR <= 2.3; Total bilirubin <= 3x ULN; AST/ALT <= 5x ULN; Albumin >= 2.8 g/dL; Serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 mL/min/1.73 m^2; Urinary protein <= 1+ on dipstick or < 1 g/24 hours; NYHA class 2B or better; QTc interval <= 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Mayo Clinic Arizona · Scottsdale, Arizona
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify