Liver Cancer
Conditions
Interventions
experimental group:Camrelizumab and FOLFOX chemotherapy by hepatic artery infusion combined with apatinib mesylate
Sponsors
The First Affiliated Hospital of Nanyang Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Patients with HCC who are in strict compliance with the clinical diagnostic criteria of the "Specifications for the Diagnosis and Treatment of Primary Liver Cancer" or diagnosed by histopathological or cytological examinations, and cannot receive radical surgery; 3. There is at least a measurable lesion (according to the requirements of mRECIST, the long diameter of the spiral CT scan of the measurable lesion is >=10mm or the short diameter of enlarged lymph nodes is >=15mm); 4. The researcher thinks it can benefit; 5. The main organs and bone marrow function are basically normal: (1) Blood routine: white blood cell >=4.0x10^9/L, neutrophil >=1.5x10^9/L, platelet =90g/L; (2) Liver function: total bilirubin60mL/min; (4) International normalized ratio (INR)=50%. 6. Able to swallow pills normally; 7. The ECOG score is 0 or 1; 8. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before study entry , And must be a non-lactating patient; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 9. The subject voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the 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. Patients with contraindications to apatinib; 3. Those considered by the doctor to be unsuitable for inclusion; 4. Incomplete important imaging examinations and incomplete records of adverse reactions; 5. 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, and can be included if no intervention is required after adulthood; asthma that patients need bronchodilators for medical intervention cannot be included); 6. Patients with any severe and/uncontrolled diseases, including: active or uncontrolled serious infections; 7. Received 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 The operation or failure to recover from the side effects of any such operation; 8. Severe infections within 4 weeks before starting the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 9. 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; 10. Patients with brain metastases who are accompanied by symptoms or whose symptoms have been controlled for less than 3 months; 11. Long-term unhealed wounds or fractures; 12. 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 |
|---|---|
| Progression-free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of relief;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYang Xiuli
The First Affiliated Hospital of Nanyang Medical College
Outcome results
None listed