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

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Liver Transplantation Read More

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.