Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Hu'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join the study, sign informed consent, have good compliance, and cooperate with follow-up; 2. Aged >= 18 years (calculated on the day when the informed consent is signed); 3. Patients with hepatocellular carcinoma who have been diagnosed by pathology or meet the clinical diagnostic criteria of "Diagnosis and Treatment of Primary Liver Cancer" (2019 Edition); 4. Patients who are not suitable for / refusing surgical resection or liver transplantation, patients with residual lesions after radical resection, patients with recurrence or metastasis after surgery; 5. Previous TACE treatment times = 1.5 x 10^9/L; (2) Platelet >= 50 x10^9/L; (3) Hemoglobin >= 9g/dL; (4) Serum albumin >= 3g/dL; (5) Total bilirubin = 60mL/min.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or asthma in childhood have been completely relieved, and can be included in adults without any intervention; patients with asthma requiring medical intervention with bronchodilator can not be included; etc.); 3. Patients who are using immunosuppressive agents, or who are receiving systemic or absorbable local hormone therapy to achieve immunosuppressive purpose and are still using them within 2 weeks before enrollment (dose > 10mg / day, prednisone or other therapeutic hormones); 4. Patients with severe allergic reactions to other monoclonal antibodies; 5. Central nervous system metastasis with clinical symptoms (such as brain edema, need hormone intervention, or brain metastasis progress). Patients who have received brain or meningeal metastasis treatment in the past, such as clinical stability (MRI) has been maintained for at least 1 month, and have stopped systemic hormone treatment (dose > 10mg / day prednisone or other therapeutic hormones) for more than 2 weeks; 6. Patients with clinical symptoms of ascites or pleural effusion who need therapeutic puncture or drainage; 7. Patients with active infection or fever of unknown cause during screening and before the first administration; 8. Patients with congenital or acquired immune deficiency (such as those with HIV infection) or syphilis positive; 9. Patients with bone metastasis received palliative radiotherapy more than 5% of the bone marrow area within 4 weeks before the study; 10. Patients who have previously received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1; 11. Patients who were vaccinated with live vaccine less than 4 weeks before the application of this study or may be vaccinated during the study; 12. According to the judgment of the researcher, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the study; 13. Patients with expected survival less than 3 months; 14. Patients considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TTP;ORR;DCR;TTUP; | — |
Countries
China
Contacts
Public ContactHua Xiang
Hunan Provincial People's Hospital
Outcome results
None listed