Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
62
FOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles.
Lenvatinib: For patients with a body weight \<60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study.
Organ Transplantation Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, China
2-year recurrence-free survival
From the date of transplantation to the date of tumor recurrence or the date of tumor progression otherwise, with censoring at the date of death or last contact for event-free patients.
Time frame: 2 years
2-year overall survival
The cumulative incidence of patients surviving the next 2 years from the start of treatment.
Time frame: 2 years
Adverse event and validation of adverse event incidence
The grade and incidence of adverse events (including laboratory tests, vital signs, electrocardiogram and other safety-related indicators, especially hematological system toxicity, liver transplantation function impairment, etc.) during the study, as well as the incidence of serious adverse events.
Time frame: 2 years
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