Lenvatinib Following Liver Transplantation in Patients With High-Risk Hepatocellular Carcinoma

Inclusion Criteria:

* Patients at high risk of recurrence of hepatocellular carcinoma after liver transplantation: extended Milan criteria, without vascular invasion (except for microvascular invasion suggested by pathology after operation)

  * Male or female patients aged 18 to 75.

    * ECOG physical condition was 0-2 points.

      * Child-Pugh A grade of liver function.

        * Targeted therapy is acceptable within 1-2 months after liver transplantation. ⑥Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.

          ⑦No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation.

          ⑧Good liver, kidney and bone marrow function: serum albumin \> 28g/L, total bilirubin ≤ 3 mg/dL (51.3 umol/l), ALT and AST ≤ 5 times the upper limit of normal range; serum creatinine ≤ 1.5 times the upper limit of normal range; hemoglobin \> 90 g/L, neutrophil count (ANC) \> 1.5 \* 10 \^ 9/L, platelet count \> 60 \* 10 \^ 9/L; PT-INR \< 2.3, or PT within 6 seconds over normal upper limit.

          ⑧For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment.

          ⑨All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.

          ⑩The participants have the capability of oral medication.

          ⑾The participants must sign the consent form.

Exclusion Criteria:

* Life expectancy is less than 3 months

  * The recurrence and metastasis of hepatocellular carcinoma are highly suspected.

    * Patients are with other malignant tumors simultaneously.

      * Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.

        * Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).

          * Preoperative history of severe cardiovascular disease: congestive heart failure \> NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.

            * History of HIV infection.

              ⑧Severe clinical active infections (\> NCI-CTCAE version 3.0).

              ⑨Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).

              ⑩Patients with kidney diseases requires renal dialysis.

              ⑾Drug abuse, medical symptoms, mental illness or social status that may interfere with participants'participation in research or evaluation of research results.

              ⑿Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.

              ⒀Other anti-angiogenesis therapies, surgery, TACE, local therapy and systemic chemotherapy were given before the treatment after liver transplantation.