Hepatocellular carcinoma
Conditions
Interventions
resection
ablation:Anti-virus treatment for subject with chronic hepatitis B or hepatitis C
Standard treatment for subject with basic diseases like flu
Symptom treatment for subject with complication or adverse reaction during clinical trial.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Resection group:1.Subject who have been diagnosed with HCC through clinical examination, CT, AFP or pathological examination;2.Subject with good compliance, willing to participate the examination and sign ICF; 3.Subject without physical illness of major organs such as heart, liver, kidney, etc;4.Subject without serious liver disfunction (liver function should be at Child A or B level);5.Subject without allergic history to biologics; negative to metuximab skin test;6.Age between 18-70 years old, male or female;7.ECOG score between 0-2;8.Diameter of single tumor =5cm; Number of multiple tumor=3; microvascular invasion;9.Requirement of lab tests: ALT,AST=Reference value(Ref)*3;TBil=Ref*1.5;PLT=100×09/L; PT=Ref*1.5Ablation group:1.Subject who have been diagnosed with HCC through clinical examination, CT, AFP or pathological examination;2.Maximum diameter of single tumor=3cm; Multiple tumor: number=3cm, maximum diameter=3cm3.Subject with Child-Pugh A or B level, or reaching A or B level after liver protection therapy;4.Subject without physical illness of major organs such as heart, liver, kidney, etc;5.Subject with good compliance, willing to participate the examination and sign ICF; 6.Subject without allergic history to biologics; negative to metuximab skin test;7.Age between 18-70 years old, male or female;8.ECOG score between 0-2;9.Requirement of lab tests: ALT, AST=Reference value(Ref)*3;TBil=Ref*1.5; PLT=100×09/L; PT=Ref*1.5
Exclusion criteria
Exclusion criteria: 1.Subject with poor heart-lung function, or with serious major organ diseases; Subject who couldn’t bear resection or ablation; 2.Subject with serious cirrhosis and poor liver function as Child-Pugh C; 3.Subject with failure of major organ such as liver-kidney, heart-liver, brain, etc; 4.Subject with consciousness disfunction or unwilling to corporate; 5.Subject with thyroid disfunction or couldn’t bear thyroid block; 6.Any disease which will effects the evaluation of the investigational drug 7.Subject with extrahepatic metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine examination;renal function;liver function;Thyroid function;CT or MR; | — |
Countries
China
Contacts
Public ContactJia Fan
Outcome results
None listed