Hepatocellular Carcinoma
Conditions
Sponsors
Shandong Cancer Prevention and Treatment Institute
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old; 2. Patients with primary liver cancer or unresectable HCC with recurrence / metastasis confirmed by histopathology or cytology or in strict accordance with the clinical diagnosis standard of the diagnosis and treatment code for primary liver cancer (2019 version), and at least one measurable focus (according to RECIST Version 1.1 requires that the length of spiral CT scan of the measurable lesions >= 10 mm or the short diameter of the enlarged lymph nodes >= 15 mm); 3. Child Pugh liver function rating: Patients with grade A or better grade B (= 12 weeks; 7. Patients with HBV DNA = 90 g/L ANC >= 1.5 x 10^9/L PLT >= 60 x 10^9/L (2) Biochemical examination: ALB >= 29 g/L ALT and AST < 2.5uln; TBIL <= 2ULN Creatinine <= 1.5uln; (only one of the two indexes of albumin and bilirubin in child Pugh rating is 2 points). 9. Pregnant women of childbearing age should be excluded before entering the group; 10. Those patients who are willing to join the study, have no mental illness or other mental symptoms, have full civil capacity, are willing to sign informed consent, have good compliance and can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. For patients with liver cancer with vascular invasion or extrahepatic metastasis, the targeted drugs should be taken orally; 2. Patients with CNLC stage IIB who are not suitable for surgical resection or TACE; 3. The patients whose main portal vein was completely embolized by cancer thrombus, and the formation of collateral vessels was less; 4. Patients who have received any local treatment (including but not limited to surgery, radiotherapy, hepatic artery embolization, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) other than TACE within 4 weeks before participating in the study; 5. Subjects with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, no need for any after adulthood Asthma patients who need bronchodilator for medical intervention can not be included; 6. Those who are using immunosuppressant or systemic or absorbable local hormone treatment to achieve immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones) and are still using them within 2 weeks before entering the group; 7. Subjects who have had severe allergic reaction to the test drug; 8. Subjects with clinical symptoms or diseases of the heart that can not be well controlled, such as: (1) heart failure above NYHA Level 2, (2) unstable angina, (3) myocardial infarction within one year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc > 450ms (male), and QTc > 470ms (female); 9. Patients with abnormal coagulation (INR > 1.5 or PT > 16S), bleeding tendency or undergoing thrombolysis or anticoagulation; 10. Patients who received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy before and who were less than 4 weeks away from the last medication or treatment (or 5 drug half-lives, whichever is the longer); patients whose adverse events (except hair loss) caused by the previous treatment did not recover to <= CTCAE 1 degree; 11. Patients with clinical symptoms of ascites, pleural effusion and pericardial effusion who need therapeutic puncture or drainage, such as those who are stable after drainage of pleural effusion and pericardial effusion for at least 2 weeks before the first application of the study drug, can be included in the study; 12. Patients with severe abnormal liver function and coagulation function within the first two months of randomization; 13. Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or patients who have had arteriovenous thrombotic events in the past 6 months (to enrollment); 14. Patients with active infection or fever with unknown cause more than 38.5 degrees during screening and before the first administration; 15. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 16. Have congenital or acquired immune function defects (such as HIV infection), or active hepatitis (reference for hepatitis B: patients whose HBV DNA detection value excee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Time To Progress (TTP);Objective response rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactJianjun Han
Shandong Cancer Prevention and Treatment Institute
Outcome results
None listed