Primary liver cancer
Conditions
Interventions
experimental group:Targeted therapy + PD-1 inhibitor + interventional therapy
Sponsors
Cancer Hospital Affiliated to Guangxi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-70 years; 2. Those patients with Barcelona clinical liver cancer (BCLC) stage B or C who cannot be resected; 3. Subjects with child Pugh a liver function; 4. Subjects with ECoG score of 0 or 1; 5. Patients with hepatocellular carcinoma confirmed by histopathology or clinical diagnosis (diagnostic criteria of American Association for the study of liver diseases); 6. Subjects who did not receive systemic anti-tumor therapy for advanced liver cancer before the first administration.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with targeted drugs, anti PD or anti-PD-L1 inhibitors. 2. Patients with recurrent liver cancer. 3. Patients with poor compliance. 4. Patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA > 2000 IU / ml or 104 copies / ml; hepatitis C virus (HCV) RNA > 103 copies / ml; hepatitis B surface antigen (HBsAg); excluding HCV positive. 5. The patients who have absolutely poor blood supply of tumor focus or can not undergo TACE. 6. Patients with known history of human immunodeficiency virus (HIV) infection. 7. Patients with known tumors of other systems or metastatic liver cancer. 8. Study the subjects who had any life-threatening bleeding events within 30 days before enrollment, including the need for blood transfusion treatment, surgical or local treatment, and continuous drug treatment. 9. Subjects with a history of organ allotransplantation. 10. Subjects with any history of active autoimmune diseases or autoimmune diseases. 11. Subjects with uncontrolled pleural effusion, pericardial effusion or moderate or more ascites. 12. Subjects who are known or suspected to be allergic to the study drug or any drug related to this trial. 13. Any condition that is unstable or may endanger the safety of patients and their compliance with the study. 14. Pregnant or lactating patients. Pregnant women with fertility must have negative pregnancy test results within 7 days before starting the study drug treatment. The men and women in this trial must take adequate barrier contraceptive measures during the trial. 15. Subjects participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Operative conversion rate;Overall Survival, OS;Disease Control Rate, DCR;Duration of Response, DOR;Time to Response, TTR;Recurrence free survival, RFS; | — |
Countries
China
Contacts
Public ContactFeixiang Wu
Cancer Hospital Affiliated to Guangxi Medical University
Outcome results
None listed