Unresectable Hepatocellular Carcinoma
Conditions
Interventions
experimental group:TACE combined with Apatinib mesylate and Camrelizumab
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 and 5cm, two to three tumors with a diameter of > 3cm, or more than three tumors; 4. Child Pugh score: Grade A or better grade B (= 1.5 x 10^9 / L; B) platelet count (PLT) >= 100 x 10^9 / L; C) hemoglobin content (Hgb) >= 9.0 g / dl; D) total bilirubin (TBIL) >= 2 x upper limit of normal value (ULN); E) alanine aminotransferase (ALT) 5 x ULN; F) aspartate aminotransferase (AST) = 28 g / L; H) alkaline phosphatase (ALP) = 50ml / min (Cockcroft Gault formula); J) routine urine test results showed that urine protein = 2 +, 24-hour urine collection and 24-hour urine protein quantity < 1g should be carried out. K) International standard ratio (INR) or activated partial thromboplastin time (APTT) is less than 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation. 2. There is any active autoimmune disease or history of autoimmune disease. 3. HBV DNA > 2000 IU / ml or 104 copies / ml; HCV RNA > 10^3 copies / ml; HBsAg and anti HCV antibody were positive at the same time. 4. People with HIV infection (HIV 1 / 2 antibody positive). 5. It has been diagnosed as any other malignant tumor (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma or carcinoma in situ after radical resection). 6. Any life-threatening bleeding event occurred within 6 months before enrollment. 7. Thromboembolic events of artery and vein within 6 months before enrollment. 8. There is a high risk of bleeding, including: A) In the first 30 days, the patients had major trauma or operation; B) There are any bleeding diseases, such as hemophilia, vascular hemophilia, etc.; C) They are undergoing thrombolysis, anticoagulation or antiplatelet therapy. 9. Symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc corrected at screening > 500ms, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy. 10. Previous and current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases. 11. Serious infection in active period or poor clinical control or severe infection within 4 weeks before enrollment. 12.Immunosuppressivedrugs (excluding local glucocorticoids or systemic glucocorticoids of physiological dose, i.e. < 10 mg / day prednisone or other glucocorticoids of equivalent dose) were used within 4 weeks before enrollment. 13. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;Safety; | — |
Countries
China
Contacts
Public ContactXiao Li
Cancer Hospital of CAMS
Outcome results
None listed