FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation

Inclusion criteria

• Age between 18 and 75 years inclusive.
• Histologically confirmed hepatocellular carcinoma without other non-hepatocellular carcinoma components.
• ECOG performance status 0-1.
• Child-Pugh class A liver function.
• Eligible for chemotherapy and targeted therapy within 1-2 months after liver transplantation.
• Immunosuppressive regimen including calcineurin inhibitors, mycophenolate mofetil, and sirolimus.
• Adequate liver, kidney, and bone marrow function: serum albumin >28g/L, total bilirubin ≤3mg/dL (51.3 umol/l), ALT and AST ≤5 times the upper limit of normal; serum creatinine ≤1.5 times the upper limit of normal; hemoglobin >90g/L, absolute neutrophil count (ANC) >1.5×10^9/L, platelet count >60×10^9/L; PT-INR <1.5 or PT within normal limits +6 seconds.
• Negative serum/urine pregnancy test within 7 days prior to treatment initiation for fertile women.
• Reliable contraception must be used by all male and female participants during the trial and for six months after its completion.
• Ability to take oral medications.
• Participants must provide written informed consent.

Exclusion criteria

• Life expectancy less than 6 months.
• High suspicion of hepatocellular carcinoma recurrence and metastasis.
• Concurrent malignancies.
• Allergy to lenvatinib or chemotherapy drugs.
• Pregnant or lactating women (female participants must undergo pregnancy testing within 7 days prior to treatment).
• History of severe cardiovascular diseases: congestive heart failure >NYHA class 2; active coronary artery disease (myocardial infarction within 6 months prior to enrollment); severe arrhythmias requiring antiarrhythmic therapy (β-blockers or digoxin permitted); uncontrolled hypertension.
• History of HIV infection.
• Severe active clinical infections.
• Patients requiring medication for epilepsy (e.g., steroids or antiepileptic drugs).
• Patients with kidney diseases requiring dialysis.
• Drug abuse, medical conditions, psychiatric illnesses, or social status that may interfere with the participant's participation in the study or evaluation of study results.
• Patients unable to swallow oral medications, such as those with severe upper gastrointestinal obstruction requiring gastric tube feeding.
• Previous treatment with other anti-angiogenic therapies, surgery, TACE, local therapy, systemic chemotherapy, immunotherapy, etc., before liver transplantation.
• Clear evidence of main portal vein/hepatic vein tumor thrombus or inferior vena cava tumor thrombus.
• Clear evidence of lymph node metastasis.