Liver Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Patients with HCC who are in strict compliance with the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017 Edition) or diagnosed by histopathological or cytological examinations, and cannot receive radical surgery. 3. There are at least measurable lesions (according to the requirements of the mRECIST version, the length of the spiral CT scan of the measurable lesions is >= 10mm or the short diameter of enlarged lymph nodes is >= 15mm). 4. The researcher thinks it can benefit. 5. Join the study voluntarily, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those who are known to be allergic to apatinib and any of its excipients; 2. Pregnant or breastfeeding women; 3. Patients with contraindications to apatinib; 4. Those considered by the doctor to be unsuitable for inclusion; 5. Incomplete important imaging studies and incomplete records of adverse reactions; 6. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , Hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, without any intervention after adulthood can be included; patients with asthma that require bronchodilators for medical intervention cannot be included); 7. History of hepatic encephalopathy; 8. Patients with any severe and/uncontrolled diseases, including: patients with unsatisfactory blood pressure control (systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (Including QT interval >= 480ms) and grade I cardiac insufficiency; active or uncontrolled severe infection; liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copies/ml or 2000IU/ ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method); urine routine indicates that urine protein is >= ++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0g; 9. Known to have inherited or acquired bleeding and thrombotic tendency, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.; 10. Underwent major surgery, open biopsy, or major trauma within 28 days before starting the medication, or received abdominal intervention or major abdominal trauma within 60 days before starting the study treatment, or expected major surgery during the study period Surgery or failure to recover from the side effects of any such operations; 11. Severe infections within 4 weeks before the start of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 12. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment; 13. Patients with brain metastases who are accompanied by symptoms or whose symptoms have been controlled for less than 3 months; 14. Long-term unhealed wounds or fractures; 15. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free stage;Disease progression time;Overall survival;One-year overall survival rate;Two-years overall survival rate;Three-years overall survival rate;Objective response rate;Disease control rate;Quality of life score;Adverse events; | — |
Countries
China
Contacts
Henan Cancer Hospital