Hepatocellular Carcinoma
Conditions
Interventions
Control group:RFA
Sponsors
Sir Run Run Shaw Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The HCC patients must be strictly in accordance with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition). According to clinical diagnosis standard or confirmed by histopathology or cytology; 2. Tumor number=3, maximum tumor diameter =5 cm; 3. The BCLC stage 0 - B1; 4. The patient refused to liver transplantation or liver resection; 5. The Child - Pugh (liver function grade): grade A or better grade of B (=7 points); 6. aged 18 years old and more; 7. Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 2; 8. Life expectancy of at least 12 weeks; 9. Adequate bone marrow, liver and renal function as assessed by the following laboratory tests (without blood transfusion during 14 daysunused g-csf and other hematopoietic stimulating factor correct); HB = 90g/L; ANC=1.5×10^9/L; PLT=80×10^9/L; ALB = 29g/L (without ALB during 14 days); ALT and AST < 5×ULN; TBIL =1.5×ULN; Cr =1.5×ULN (Only one of albumin and bilirubin can be 2 points in the rating of Child-Pugh); 10. Within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward; 11. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. Major vascular tumor emboli formation and/or extrahepatic metastasis; 2. Known hepatic duct carcinoma, mixed cell carcinoma or fibrolamellar hepatocellular carcinoma, known history or suffering from other cancer(except of cured skin basal cell carcinoma or carcinoma in situ of cervix); 3. Patients who will receive liver transplantation (except for liver transplantation patients before); 4. Ascites with clinical symptoms, i.e. require Abdominal paracentesis or drainage treatment such as or Child-Pugh Score>2; 5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 6. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male = 450 ms, female= 470 ms); 7. Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF 1.5 x ULN, or PT > ULN +4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 12.Occurrence of central nervous system metastatic or known brain metastatic; 13. Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.; 14. Proteinuria = (++) or 24 hours total urine protein > 1.0 g; 15. Pregnant or breast-feeding women; patients with fertility will not or there is no way to adopt effective contraceptive measures; 16. Patients with HIV infection; 17. Other conditions regimented at investigators' discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR;Safety; | — |
Countries
China
Contacts
Public ContactYong Fang
Sir Run Run Shaw Hospital
Outcome results
None listed