hepatocellular carcinoma
Conditions
Interventions
Group 2:TACE+Apatinib
Group 1:TACE+Placebo
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old patients with hepatocellular carcinoma, the pre-survival period is more than 12 weeks; 2. Liver cancer lesions meet the BCLC-A/B/C phase; 3. Liver function Child-Pugh score = 7 points; 4. ECOG score = 1 point; 5. The main organs function normally, meeting the following criteria: (1) blood routine examination: hemoglobin (HB) = 90 g/L; white blood cells (ANC) = 3.5 × 10^9/L; platelets (PLT) = 60 × 10^9/L; (2) biochemical examination: albumin (ALB) = 35 g/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5xULN; total biliary red TBIL =30umol/L; creatinine =1.5xULN; 6. The patient and/or family agree to join the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The portal vein is completely embolized and the collateral vessels are less formed; 2. Extrahepatic spread, including patients with inferior vena cava invasion; 3. Patients preparing for liver transplantation; 4. Patients with diffuse liver cancer; 5. AFP 1.5 or prothrombin time (PT) > ULN + 4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; coagulation function is severely reduced, and can not be corrected; 7. Received molecular targeted drug therapy, radiotherapy, chemotherapy, etc. other than apatinib before enrollment; 8. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including men with QTc interval = 450 ms, women = 470 ms); 9. Patients with severe pulmonary function abnormalities; 10. The tumor volume exceeds 70% of the liver volume; 11. Patients who are allergic to any component of apatinib; 12. Patients with active bleeding; 13. Patients with peptic ulcer, intestinal perforation or intestinal obstruction; 14. Patients within 30 days after major surgery; 15. In patients with hypertension, blood pressure is still poorly controlled by antihypertensive drugs (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg); 16. Urine routinely showed urinary protein = ++ or confirmed 24-hour urine protein quantitation > 1.0g; 17. Pregnant or lactating female patients; 18. Have a history of mental illness or psychotropic substance abuse; 19. Patients and/or family members do not agree to join a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time of tumor progression;Time-to-unTACEable progression TTUP; | — |
Countries
China
Contacts
Public ContactLiu Chang
West China Hospital, Sichuan University
Outcome results
None listed