Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery

Inclusion Criteria

• •Certainly, here is the translation of the provided text into English:
• •1. Age between 18 to 80 years old, gender not limited;
• •2. Received radical treatment surgery for liver cancer within 4 to 8 weeks prior to enrollment, and meet the following criteria: (1) Intraoperative judgment criteria: ① No gross tumor thrombus in the hepatic vein, portal vein, bile duct, and inferior vena cava; ② No invasion of adjacent organs, no hepatic hilum lymph nodes or distant metastasis; ③ The liver resection margin is ≥1cm from the tumor border; if the margin is less than 1cm, the histological examination of the resected liver surface shows no residual tumor cells, i.e., negative resection margin. (2) Postoperative judgment criteria: ① Ultrasound, computed tomography(CT), magnetic resonance imaging(MRI) examinations (at least two of these) are performed within 1 to 2 months after surgery, with no residual or recurrent tumor lesions in radical resection cases, and no active tumor lesions in radical ablation cases; ② If serum alpha-fetoprotein(AFP), des-gamma-carboxy prothrombin(DCP), and a combination of 7 Micro ribonucleic acid(microRNAs) and other tumor markers were elevated before surgery, then quantitative measurement of tumor markers is required 8 weeks after surgery, and their levels drop to the normal range; if serum alpha-fetoprotein(AFP) does not return to normal within 8 weeks after surgery , will not be included.
• •3. Postoperative pathological examination confirms hepatocellular carcinoma(HCC), and all tumor nodules are completely removed with negative resection margins.
• •4. Imaging examinations ≥4 weeks after surgery confirm no recurrence or metastasis.
• •5. Expected survival \>3 months;
• •6. hepatitis B virus(HBV) deoxyribonucleic acid(DNA) \<10\^4 copies/ml (2000 IU/ml), if hepatitis B virus(HBV) deoxyribonucleic acid(DNA) ≥10\^4 copies/ml, antiviral treatment should be initiated first until hepatitis B virus(HBV) deoxyribonucleic acid(DNA) is reduced to below 10\^4 copies/ml before entering the study, and continue to take antiviral medication and monitor liver function and hepatitis B virus(HBV) load.
• •7. At least one of the following high recurrence risk factors exists:
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• •1. Tumor diameter \>5cm
• •2. Multiple lesions (\>3)
• •3. Pathology indicates MVI positivity
• •4. Edmondson III-IV grade
• •5. Persistently abnormal alpha-fetoprotein 8. No history of other tumors, and no antitumor treatment before surgery; 9. Eastern Cooperative Oncology Group(ECOG) score: 0-1. 10. Major organ functions are normal, i.e., meeting the following criteria:
• •Hematology examination (within 14 days before screening, without blood transfusion or use of granulocyte colony stimulating factor(G-CSF)):
• •1. Hemoglobin ≥90 g/L;
• •2. Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
• •3. Platelet count ≥75×10\^9/L;
• •Biochemical examination (within 14 days before screening, without the use of albumin):
• •4. Albumin ≥28 g/L;
• •5. Total bilirubin ≤1.5×upper limit of normal (ULN);
• •6. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤3×ULN;
• •7. Creatinine ≤1.5×ULN;
• •Coagulation function:
• •8. International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
• •9. Activated partial thromboplastin time (APTT) ≤1.5×ULN. 11.Patients with reproductive capacity, both male and female, must use reliable contraceptive measures during the study medication use and for 60 days after the last dose.