Adjuvant Therapy With Anlotinib for HCC

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, anlotinib, adjuvant, surgery Read More

Inclusion Criteria:

• Aged from 18-75 years.
• HCC diagnosis was confirmed by pathological examination and those who did not receive anti-tumor treatment (anti-tumor treatment including but not limited to: local ablation therapy, TACE, radiation therapy, chemotherapy, targeted drug therapy, immunotherapy, and etc.)
• Underwent curative resection for HCC with high risk of tumor recurrence, which was defined by Shanghai Score ≥ 4.922 (Sun, et al. Chin Med J (Engl) 2017)
• Child-Pugh class: A or B7
• The ECOG Performance Status: 0-1 points
• The expected survival time ≥ 6 months
• No disease recurrence 4-6 weeks after surgery as evaluated by abdominal contrast-enhanced CT/MRI and chest CT.
• Adequate organs function
• Complete blood counting HB ≥ 90 g/L ANC ≥ 1.5×10^9 /L PLT ≥ 75×10^9/L
• Blood biochemistry ALB ≥ 28 g/L ALT and AST< 5×ULN TBIL ≤ 2×ULN Serum creatinine ≤ 1×ULN
• Women of childbearing age must have pregnancy tests within 7 days prior to admission, and the results are negative and are willing to use appropriate methods of contraception at 8 weeks after the trial and at the end of the trial. For men, surgical sterilization should be applied, or consent to use appropriate methods of contraception 8 weeks after the trial and at the end of the trial.
• Subjects voluntarily participated in the study, signed informed consent, good compliance in drug therapy and followed up.

Exclusion Criteria:

• Cholangiocarcinoma, the combination of cholangiocarcinoma of HCC, or fibrolamellar HCC diagnosed by pathology examination.
• Past or current diagnosed with other malignancy, except skin basal cell carcinoma and cervical carcinoma in situ.
• Those treated with liver or other organ transplantation or willing to undergo liver transplantation.
• The conditions not suitable for oral medications, including difficulty swallowing, chronic diarrhoea, or bowel obstruction.

• Vascular events within 6 months, including stroke and transient ischemic attack

  , deep venous thrombosis or pulmonary artery embolism.

• Alimentary tract hemorrhage or high risk of alimentary tract hemorrhage due to esophageal varices, active ulcerative lesions or ulcerative colitis; or fecal occult blood test ≥ ++, or for those with fecal occult blood test (+), gastroscopy is required.
• Abnormal coagulation function (international normalized ratio > 2, prothrombin time > 16 s, thrombin time >21s, activated partial thromboplastin time > 21 s, or fibrinogen < 2 g/L); or other conditions with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
• Other severe or uncontrolled comorbidities:
• hypertension and the blood pressure was not well managed by medications (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 90 mmHg); level 2 or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥ 480 ms); level 1 heart dysfunction; or LVEF < 50%.
• active or uncontrolled infection.
• uncontrolled diabetes (fasting blood glucose > 10 mmol/L).
• Urinary protein ≥ ++ or 24 hours urine protein > 1 g.
• Unhealed wounds, ulcer, or bone fracture.
• Those with mental illness or a history of psychotropic substance abuse; HIV infection.
• Other conditions that the investigators considered that not suitable for trial inclusion.