Hepatocellular Carcinoma
Conditions
Interventions
sorafenib and TACE:sorafenib and TACE
Sponsors
Zhongda Hospital, Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, both male and female; 2. Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST); 3. Patients with confirmed HCC; 4. Child-Pugh3 nodules), and no cancer related symptoms (PS=0); (2) BCLC-C: patients with a Child Pugh class A or B, and with anyone in the list: patients with hepatic vascular involvement (at any tumor number and diameter), no cancer related symptoms (PS=1-2), presence of extra-hepatic tumor spread; (3) The largest tumor diameter =12 weeks; 8. sufficient liver and kidney function; (1) AST, ALT =9g/dl; (2) Platelet count >=50*10^9/L; (3) Absolute neutrophil count (ANC)> 1500/mm3; (4) A normal clotting time(slide method of the normal clotting time is 1 to 5 minutes, test-tube method of normal for 4 to 12).
Exclusion criteria
Exclusion criteria: 1. the patient's specific circumstances (such as the severity of hepatic cirrhosis, etc.) not suitable for TACE treatment; 2. BCLC stage A or D for the period; 3. In the 4 weeks before enrollment or during the use of chemotherapy or immunotherapy; 4. The presence of artery and vein leakage in patients; 5. decompensated liver function, or the existence of hepatic encephalopathy; 6. 30 days before entering the study had gastrointestinal bleeding events; 7. pregnant or lactating women; 8. active bleeding or sepsis; 9. allergic to intravenous contrast agents; 10. history of heart disease: (1) NYHA 2 and above of congestive heart failure, symptomatic coronary artery disease; (2) Need to treat the arrhythmia with drug outside beta-blockers or digoxin therapy; 11. despite treatment, systolic blood pressure remains> 150 mmHg or diastolic blood pressure> 90 mmHg in blood pressure; 12. not cure severe trauma, acute or incurable ulcer, or a fracture within 3 months; 13. not oral drugs; 14. The researchers believe that the poor compliance; 15. there has been the primary lesion, or both, or different histology of HCC tumors, except: head and neck carcinoma in situ, curable basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and into the group three years ago. have been cured of cancer; 16. Severe active infection (> 2, NCI-CTCAE 3.0); 17. HIV infection or AIDS-related disease exists, or severe acute and chronic diseases; 18. substance abuse, or may interfere with study compliance with the psychological or mental diseases; 19. require drug treatment of epilepsy patients (eg, steroids, or antiepileptic drugs); 20. The presence of sorafenib or doxorubicin contraindications; 21. unstable or likely to endanger any patients in this study the safety and compliance situation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;PFS;OS;AFP; | — |
Countries
China
Contacts
Public ContactGao-Jun Teng
Outcome results
None listed