Hepatocellular carcinoma
Conditions
Interventions
experimental group:cryoablation+TACE
Control:TACE treatment
Sponsors
The Afiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Prior informed consent; 2. Confirmed Diagnosis of HCC: 2.1. Cirrhotic subjects: Clinical diagnosis by AASLD criteriaHCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria; 2.2. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory.Documentation of original biopsy for diagnosis is acceptable; 3. BCLC stage C HCC; 4. Child Pugh class A/B (== 18 years of age; 8. Life expectancy of at least 8 weeks; 9. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial; Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization: Hemoglobin > 9.0 g/dl; Absolute neutrophil count (ANC) >1,500/mm3; Platelet count 50*10^9/L; ALB>=28g/L; Total bilirubin < 2 mg/dL; ALT and AST < 5*upper limit of normal; BUN and creatinine < 1.5*upper limit of normal; INR < 1.7, or PT < 4 seconds above control.
Exclusion criteria
Exclusion criteria: 1. Biliary tract obstruction; 2.Any contraindications for TACE or cryoablation (known hepatofugal blood flow, known portal-systemic shunt, renal failure/insufficiency requiring hemo-or peritoneal dialysis); 3. Previous or concurrent cancer that is distinct in primary site or histology from HCC. Any cancer curatively treated >3 years prior to entry is permitted; 4. Prior transarterial embolization or anti-tumor systemic chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;immune cell; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression;Disease Control Rate ;AE;tumor marker; | — |
Countries
China
Contacts
Public ContactWukui Huang
Outcome results
None listed