hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign the informed consent; 2. Aged 18-75 years, no gender limit; 3. Patients with primary hepatocellular carcinoma; 4. According to the National Health and Family Planning Commission of the People's Republic of China for the diagnosis and treatment of primary liver cancer (2017 edition) clinical staging of liver cancer, patients with stage Ia-IIIa; 5. Child-Pugh score= 5 cm; (2) Single tumor patients: patients with tumor diameter =400 ng/mL; (3) Multiple tumor patients); 8. ECOG score 0-2 points; 9. Normal function of major organs (white blood cell count >= 3 x 10^9 /L, neutrophil count >= 1.5 x 10^9 /L, hemoglobin >= 85g /L, platelet count >= 80 x 10^9 /L, lymphocyte count between 0.6 x 10^9 /L (inclusive) - 4 x 10^9 /L (inclusive) (If the lymphocyte count is not reported in the blood routine report, the lymphocyte count is calculated by white blood cell count x lymphocyte percentage), blood urea nitrogen (BUN) and serum creatinine =34g/L, total bilirubin <=34.2 µmol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both less than or equal to 2.5 times the upper limit of normal); 11. The coagulation function is basically normal (PT prolongation <=4s); 12. Patients with non-viral primary liver cancer are suitable for inclusion; if it is hepatitis B-related primary liver cancer (HBV-HCC) or hepatitis C-related primary liver cancer (HCV-HCC), patients with active viral infection can be treated with antiviral therapy at the same time; 13. The expected survival period is more than 6 months.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of immunodeficiency or autoimmune diseases (such as rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); 2. Patients with a history of other malignant tumors in the past 5 years; 3. Patients who received chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, and hormone therapy within 1 month before screening; 4. Patients who have received liver tumor microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local ablation treatments; 5. Patients with severe allergic history; 6. Patients with severe mental illness; 7. Pregnant or lactating patients: or patients of childbearing age who have a positive blood pregnancy test, and patients of childbearing age and their spouses are unwilling to take effective contraceptive measures during the clinical study and within 6 months after the end of the study; 8. Patients who participated in other clinical trials within 4 weeks before this clinical trial; 9. AIDS or syphilis carriers; 10. Patients with sepsis and other infections and fever that are not effectively controlled; 11. Patients after organ transplantation; 12. Bone marrow transplant patients; 13. Those who have a history of drug abuse or alcoholism but refuse to quit drinking; 14. Patients who are considered by the investigator to be unsuitable for this clinical trial (such as poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month disease-free survival rate;Overall survival;Time to relapse; | — |
Countries
China
Contacts
First Affiliated Hospital of Zhengzhou University