hepatocellular carcinoma
Conditions
Interventions
control group:TACE combined with apatinib
blank group:TACE
Sponsors
Wuhan Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old hepatocellular carcinoma patients with a pre-survival period of more than 12 weeks; 2. HCC lesions consistent with BCLC-B / C phase; 3. Child-Pugh score of liver function = 7 points; 4. ECOG score = 1 point; 5. 0-2 TACE treatment before surgery; 6. The main organs function normally and meet the following criteria: (1) blood routine examination: hemoglobin (HB) = 90 g/L; white blood cells (ANC) = 1.5 × 10^9/L; platelet (PLT) = 60×10^9/L; (2) biochemical examination: albumin (ALB) = 29 g/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5× ULN; total bilirubin (TBIL) = 50umol/L; creatinine = 1.5× ULN; 7. Patients and / or family members agreed to join clinical trials and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The portal vein was completely embolized, and the collateral vessels were less formed; 2. Extrahepatic spread, including patients with inferior vena cava invasion; 3. Patients preparing for liver transplantation; 4. Abnormal coagulation (INR>1.5 Or prothrombin time (PT) > ULN + 4 seconds), with bleeding tendency or receiving thrombolysis or anticoagulant therapy; 5. Before the enrollment, received molecular targeted drug therapy other than apatinib, radiotherapy , chemotherapy, etc.; 6. Patients with grade II or higher myocardial ischemia or myocardial infarction and poor controlled arrhythmia(including men with QTc interval = 450 ms, women = 470 ms); 7. Patients with severe pulmonary function abnormalities; 8. Tumor volume exceeds 70% of liver volume; 9. Patients who are allergic to any component of apatinib; 10. Patients with active bleeding; 11. Patients with digestive ulcer, intestinal perforation or intestinal obstruction; 12. Patients within 30 days after major surgery; 13. Hypertensive patients, whose blood pressure is still poorly controlled by antihypertensive drugs (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg); 14. Urine routinely shows urine protein = ++ or confirmed 24-hour urine protein Quantitative >1.0g; 15. Pregnant or lactating female patients; 16. Have a mental illness, or a history of psychotropic substance abuse; 17. Patients and (or) families do not agree to join a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactChuangshen Zhen
Wuhan Union Hospital
Outcome results
None listed