Liver cancer
Conditions
Interventions
The experimental group:Camrelizumab, TACE, antiangiogenic agents
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 70 years old, regardless of gender; 2. The subjects who were diagnosed as primary hepatocellular carcinoma by histopathological examination; 3. Subjects with child Pugh score of stage a or B; 4. Subjects with BCLC stage B / C, cnlc2019 stage II B / III a (Annex 3), without extrahepatic metastasis according to preoperative evaluation; 5. If hepatectomy is performed, the remaining liver volume should be more than 40% of the standard liver volume (patients with cirrhosis) or more than 30% of the standard liver volume (patients without cirrhosis); Indocyanine green 15 minute metabolic test (ICG R15) = 1.5 x 10^9/L (2) Platelet >= 75 x 10^9/L (3) Hemoglobin >= 90g / L; (4) Serum bilirubin = 30 g / L; (7) Subjects without anticoagulant therapy: INR or APTT = 50 ml / min. Creatinine clearance was estimated based on Cockcroft Gault formula. 13. If HBsAg (+) and / or HBcAb (+), antiviral therapy is needed according to the results of HBV DNA or HCV RNA detection; 14. Subjects of women of childbearing age must conduct serum pregnancy test within 14 days before the start of study treatment, and the result is negative, and they are willing to use reliable contraceptive methods during the trial period and 60 days after the last administration of the trial drug. For male subjects whose partners are women of childbearing age, they should agree to use reliable contraceptive methods during the trial period and 120 days after the last administration of the trial drug; 15. Subjects who have fully understood the study and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those subjects with known fibrolamellar HCC, cholangiocarcinoma and mixed hepatocellular carcinoma; 2. Subjects with active malignancies other than HCC within 5 years before enrollment or at the same time. The cured localized tumors, including basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder carcinoma, carcinoma in situ of prostate, carcinoma in situ of cervix and carcinoma in situ of breast, were excluded; 3. Patients who have received systemic anticancer therapy for HCC (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1 / PD-L1 monoclonal antibody immunotherapy) and patients who have received local therapy for liver, such as TACE, TAE, tare or local ablation, radiotherapy, etc; 4. Patients with major cardiovascular and cerebrovascular diseases (such as NYHA class II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or angina pectoris within 3 months before the start of study treatment; Or left ventricular ejection fraction (LVEF) 10mg prednisone / day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids could be enrolled; 9. Patients with abnormal coagulation function (PT > 18S, INR > 1.5, FBG < 2G / L) have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 10. Patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before the first treatment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or vasculitis, etc; 11. It is known that the subjects have been allergic to those patients with macromolecular protein preparations or any component of karelizumab; 12. Patients with active infection requiring systemic treatment; 13. Patients with iodine allergy; 14. Subjects with grade III or above myelosuppression (WBC < 1.9) x 10^9 / L, hemoglobin lower than 79 g / L, platelet lower than 49 g / L x 10^9/L) 15. In patients with severe hepatic and renal insufficiency, serum albumin was lower than 28g / L, or serum bilirubin was higher than 50g / L µ The serum alanine transferase was more than 1 times of normal; 16. Human immunodeficiency virus (HIV, HIV 1 / 2 antibody) positive patients; 17. Subjects who received or will receive live vaccine within 30 days before administration of karelizumab; 18. Patients with a histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response; | — |
Countries
China
Contacts
Public ContactDecai Yu
Nanjing Drum Tower Hospital
Outcome results
None listed