Liver cancer
Conditions
Interventions
Sponsors
Nanjing Gulou Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient must sign an informed consent form and must be willing and able to comply with the visit, treatment plan, laboratory tests and other requirements of the research schedule; 2. Aged 18 to 70 years, gender is not limited; 3. Histopathological examination confirmed HCC, provide existing tumor tissue specimens or recently collected tumor tissue wax blocks, or provide 5-8 qualified white films, Child-Pugh score A; 4. BCLC staging is stage B or C, preoperative evaluation of no extrahepatic metastasis; 5. The remaining liver volume must account for more than 40% of the standard liver volume (patients with cirrhosis), or more than 30% (patients without cirrhosis); the 15 minute metabolic test of indocyanine green (ICG R15) 3, but the tumor is confined to the same segment or the same side of the liver; 8. Combined with portal vein or branch cancer, it is expected that the intraoperative tumor thrombus can be completely removed; 9. The tumor is adjacent to the hilar part, and the first stage operation is difficult; 10. ECOG physical status score 0-1 points; 11. Within 14 days before the Child-PughA~B7 level, the laboratory test value must meet the following criteria (no blood transfusion, no hematopoietic stimulating factor and human albumin within 14 days before screening): a) Neutrophils >= 1.5x10^9/L; b) Platelets >= 75x10^9/L; c) hemoglobin >= 90g / L; d) serum bilirubin = 30 g / L; g) Subjects who did not receive anticoagulant therapy: INR or aPTT = 50 mL / min. Creatinine clearance is estimated based on the Cockcroft-Gault formula. 12. If HBsAg(+) and/or HBcAb(+) require HBV DNA to be <2000 IU/mL, and receive anti-HBV treatment throughout the study period, or use entecavir throughout the study. If the HCV antibody test results are positive, the investigator decides whether to give antiviral therapy; 13. Women of childbearing age must undergo a serum pregnancy test within 14 days prior to the start of the study treatment and the results are negative, and are willing to use a reliable method of contraception during the test period and 60 days after the last administration of the test drug. For male subjects whose partners are women of childbearing age, they should agree to use reliable methods of contraception during the trial period and 120 days after the last administration of the test drug; 14. The study has been fully informed and voluntarily signed the Informed Consent (ICF).
Exclusion criteria
Exclusion criteria: 1. Fibrous layer HCC, cholangiocarcinoma and mixed liver cancer are known; 2. In the first 5 years of enrollment or at the same time with active malignant tumors other than HCC. Localized tumors that have been cured, including cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ; 3. Previously received systemic anticancer therapy for HCC (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1/PD-L1 monoclonal antibody immunotherapy) and previous treatments for liver, including Subjects such as TACE, TAE (transcatheter arterial embolization), TARE (transcatheter embolization via transcatheter arterial), or local ablation; 4. Major cardiovascular and cerebrovascular diseases within 3 months prior to the start of study treatment (eg, New York Heart Association grade II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or angina; or cardiac ultrasound examination LVEF (left ventricular ejection fraction) = 10^4 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring simultaneous antiviral therapy); 6. There is active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to treatment should be excluded, even if they have been treated; patients with a history of active tuberculosis infection more than 1 year ago should be excluded unless they have previously demonstrated standardized anti-tuberculosis treatment. 7. Active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, pituititis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and the need for bronchodilators) Treated asthma, etc.). Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy (such as vitiligo, psoriasis, or alopecia) may be enrolled. 8. Previously had interstitial lung disease, or (non-infectious) pneumonia and required oral or intravenous steroid therapy; 9. Long-term exposure to systemic sex hormones (dose equivalent to >10 mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids may be enrolled; 10. Coagulation abnormalities (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), have bleeding tendency or are undergoing thrombolysis or anticoagulant therapy; 11. There are significant clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or vasculitis; 12. The subject is known to have been previously allergic to macromolecular protein preparations, or any of the SHR-1210 components; 13. Active infections that require systemic treatment. 14. Human immunodeficiency virus (HIV, HIV 1/2 antibody) is positive. 15. Inoculated or immunized live vaccine within 30 days prior to SHR-1210 administration. 16. History of psychotropic substance abuse, alcohol abuse or drug abuse. 17. Other factors that may be affected by the investigator that may affect the safety of the subject or the compliance of the test. Serious illnesses (including mental illness), serious laboratory tests, or other family or social factors that require co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;pPR;ORR;DCR;Radical surgery rate;RFS;OS;safety; | — |
Countries
China
Contacts
Public ContactDecai Yu
Nanjing Gulou Hospital
Outcome results
None listed