Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
Trial Parameters
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.
Eligibility Criteria
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) (with