hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75 years; 3. Hepatocellular carcinoma (HCC) related to HBV or HCV infection; 4. HCC confirmed by imaging or not confirmed by imaging but confirmed by pathology (AALSD diagnostic criteria); 5. BCLC stages 0, A, B; 6. Child-Pugh classification A and B (3 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) >=1.5x10^9 /L when no granulocyte colony stimulating factor is used in the past 14 days; (2) In the case of no blood transfusion in the past 14 days, platelets >=50x10^9 /L; (3) In the past 14 days without blood transfusion or erythropoietin, hemoglobin>9g/dL; (4) Total bilirubinULN but direct bilirubin= 60 ml/min; (7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Liver cancer related to autoimmune diseases; 2. Received anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks before the first treatment; 3. An active self that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressive agents) occurred within 2 years before the first treatment Sexual immune disease. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 4. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first treatment of the study; 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Participated in other drug trials (except traditional Chinese medicine) within the past three months; 7. Those who cannot accept intravenous injection; 8. Any other factors that the researcher thinks are not suitable for entering the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival;Overall survival; | — |
Countries
China
Contacts
Beijing Youan Hospital Capital Medical University