Liver cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. patients with liver cancer diagnosed according to the clinical diagnostic criteria of the Diagnosis and Treatment Specifications for Primary Liver Cancer (2019 Edition); 2. patients with refractory HCC; (meet at least one of the following): (1) huge cancer especially closely connected with the diaphragm or adjacent organs or even invaded; (2) liver cancer involving the main branches or main trunk of the portal vein; (3) special sites of liver cancer: segments I, VIII, IX; (4) recurrence after resection of liver cancer with extensive dense adhesion; 3. No previous local treatment and systemic treatment for the tumor; 4. at least one measurable tumor according to RECIST version 1.1; 5. ECOG score 0-1 points; 6. Estimated survival period >= 3 months; 7. Child-Pugh score =1.5x10^9/L; (2) PLT >=80x10^9/L; (2) biochemical examination need to meet the following criteria: (1) TBIL 45ml/min (Cockcroft-Gault formula); 10. It is available to provide preoperative tissue samples and/or intraoperative tissue and blood samples for PD-L1 or TMB detection for subsequent analysis; 11. Patients with potential fertility, need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 1 month after the end of study treatment; and need to have a negative serum or urine HCG test within 72 hours before study entry, and must be non-lactating; 12. Aged 18-80 years old; 13. Those patients who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. BMI =10% within 2 months before screening (considering the effect of a large amount of ascites on weight); 2. coagulation abnormalities (INR > 1.5APTT > 1.5ULN), with bleeding tendency; patients with potential bleeding risk; 3. patients with uncontrolled hypertension; 4. Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 5. History of hepatic encephalopathy, or history of liver transplantation; 6. previous history of allergy to any component of the test drug: cabazitaxel, apatinib mesylate; 7. poor control of refractory pleural, abdominal or pericardial effusion in subjects; 8. previous immunotherapy with anti-PD-1 or PD-L1 or CTLA-4 or Car-T; 9. History of interstitial lung disease (except radiation pneumonitis not treated with hormone therapy), pneumonitis; 10. subjects with 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, hypothyroidism; subjects with vitiligo or childhood asthma has been completely relieved, no intervention after adulthood can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included); 11. Subjects are using immunosuppressive agents, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment; 12. Serious infection (CTCAE > grade 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging showed active pulmonary inflammation, symptoms and signs of infection 2 weeks before the first use of the study drug or the need for oral and intravenous antibiotic treatment, except for the prophylactic use of antibiotics; 13. The subject had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome within 1 month, cardiovascular clinical symptoms or diseases failed to be well controlled; 14. The subject had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 15. According to NYHA criteria, grade III-IV cardiac insufficiency, or echocardiography showed that the score (LVEF) < 50%; 16. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: there are local active ulcer lesions, and fecal occult blood {(+ +) can not be}; 2 months with a history of melena, hematemesis; 17. Wounds or fractures that have not been cured for a long time; Major surgical procedures or severe traumatic injuries, fractures or ulcers; 18. Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV virus or RNA detection value exceeds the upper limit of normal); 19. Patients with a history of psychiatric drug abuse and unable to quit or patients with mental disorders; 20. According to the investigator's judgment, patients with c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR Rate;RFS;OS;QoL;Safety; | — |
Countries
China
Contacts
Public ContactHu Sanyuan
Shandong Provincial Qianfoshan Hospital
Outcome results
None listed