The Study of The Treatment of Postoperative Adjuvant Apatinib vs. TACE in Hepatocellular Carcinoma Patients

This is an interventional treatment trial for Hepatocellular Carcinoma Read More

Inclusion Criteria:

1. Age: ≥18 years old;
2. HCC diagnosed by histopathology or cytology (including pathological margin positive lesions, residual positive lesions after DSA angiography, combined vascular tumor thrombus and/or biliary tumor thrombus, pathologically confirmed lymph node metastasis, and liver The tumor ruptured, adjacent organs were invaded, the number of tumors was ≥ 3, AFP did not fall to normal range at 2 months after operation, and pathologically confirmed vegf + or patients with microvascular invasion.
3. Child-Pugh Liver Function Rating: Grade A or better Grade B (≤ 7 points);
4. ECOG PS score: 0-1 points;
5. Expected survival period ≥ 12 weeks;
6. The normal function of the major organs is the following:

(1) Blood tests: HB≥90 g/L; ANC≥1.5×109/L; PLT≥60×109/L; (2) Biochemical tests: ALB ≥29 g/L; ALT and AST<2.5ULN; TBIL ≤ 2ULN; Creatinine ≤1.5ULN; (Child-Pugh can only have 2 points for both albumin and bilirubin) 7. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment; 8. Subjects voluntarily joined the study, signed informed consent, and adhered well to follow-up.

Exclusion Criteria:

1. Have received systematic treatment in the past;
2. Hepatobiliary cell carcinoma and mixed cell carcinoma and fibrous lamellar cell carcinoma are known; in the past (within 5 years) or with other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
3. Patients who are preparing for liver transplantation (except those who have previously undergone liver transplantation);
4. Ascites with clinical symptoms, which require therapeutic paracentesis or drainage;
5. People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
6. Arrhythmia with grade II or higher myocardial ischemia or myocardial infarction and poor control (including QMS interval men ≥450 ms, women ≥470 ms);
7. In accordance with NYHA criteria III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
8. Has a variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption);
9. In the past 6 months, there was a history of digestive tract bleeding or a clear tendency to gastrointestinal bleeding. For example, esophageal varices, local active ulcer lesions, fecal occult blood ≥ (++) may not enter the group. If fecal occult blood (+) requires gastroscopy;
10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study;
11. Coagulation abnormalities (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds) with a tendency to hemorrhage or receiving thrombolytic or anticoagulant therapy;
12. Patients with central nervous system metastases or known brain metastases have occurred;
13. Patients with objective evidence of previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impaired lung function;
14. Urine routine showed urinary protein ≥ ++ or confirmed 24-hour urinary protein quantification> 1.0 g;
15. Was treated with potent CYP3A4 inhibitors within 7 days before participating in the study or was treated with potent CYP3A4 inducer within 12 days prior to study participation;
16. Pregnancy or breastfeeding women; those with fertility who are unwilling or unable to take effective contraceptive measures;
17. There is a history of mental illness or abuse of psychotropic substances;
18. Patients with bone metastases who have received palliative radiotherapy (radiotherapy area> 5% bone marrow area) within 4 weeks before participating in the study;
19. Joint HIV-infected patients.