TerminatedPhase 2

Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant

Stopped: Slow Accrual

United States3 participantsStarted 2022-04-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%) * Patients must have recurrent histologically or cytologically confirmed hepatocellular carcinoma that has recurred after liver transplantation and not amenable for surgical resection * Child Pugh class A * Prior orthotropic liver transplantation for curative intent * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Life expectancy \> 12 weeks as determined by the investigator * Hemoglobin \>= 8.0 g/dl (within 28 days of cycle 1 day 1) * Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1; after at least 7 days without growth factor support or transfusion) * Platelets \>= 75,000/mcL (within 28 days of cycle 1 day 1) * International normalized ratio (INR) =\< 2.3 (within 28 days of cycle 1 day 1) * Total bilirubin =\< 3 times the institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5.0 times the ULN (within 28 days of cycle 1 day 1) * Albumin \>= 2.8 g/dL (within 28 days of cycle 1 day 1) * 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; creatinine clearance should be calculated per institutional standard (within 28 days of cycle 1 day 1) * Urinary protein =\< 1+ on dipstick or routine urinalysi…

What they're measuring

Overall response rate (ORR)

Timeframe: Up to 2 years

Trial details

NCT IDNCT05103904

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-09