Primary hepatocellular carcinoma
Conditions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The clinical histopathological diagnosis is advanced metastatic hepatocellular carcinoma; 2. Have received standard treatment (targeted therapy or chemotherapy) failed or cannot tolerate; 3. Aged 18-75 years on the day of signing the informed consent; 4. ECOG score 0-2 points, Child Pugh A grade; 5. According to the solid tumor curative effect evaluation standard version 1.1 (RECIST v1.1), there are at least >=1 measurable lesions, or >=1 measurable lesions with clear progress after local treatment (based on RECIST v1.1 standards); at the same time; with >=1 radiotherapy focus and imaging can assess the remote effect of the focus; 6. Life expectancy >= 12 weeks; 7. Controlled hepatitis B subjects need to meet the following criteria to be eligible to participate in the study: Have received HBV antiviral therapy for at least 1 month before the first administration of the study drug, and the HBV viral load must be less than 2000 IU/mL (104 copies/mL) before the first administration; For subjects who are receiving anti-HBV treatment with a viral load of less than 2000 IU/mL (104 copies/mL), the same treatment should be maintained throughout the study treatment period. 8. The main organ functions meet the following criteria within 28 days before treatment: (1) Blood routine examination standard (under no blood transfusion within 14 days): hemoglobin (HB) >=80g/L; absolute value of neutrophils (ANC) >=1.5x10^9/L; platelets (PLT) >=80x 10^9/L; (2) Biochemical examination should meet the following standards: total bilirubin (TBIL) =60ml/min; (3) The coagulation test must meet the following standards: International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 ULN; Active Partial Thromboplastin Time (APTT) <= 1.5 ULN (If the subject is receiving anticoagulation therapy, as long as the PT and APTT are within the expected treatment range); (4) Thyroid function: T3 and T4 levels are normal after drug treatment; 9. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and 120 days after the end of the study; serum or urine pregnancy tests are negative within 7 days before study entry; 10. Agree and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have received immune checkpoint inhibitor therapy in the past; 2. Known to have allergic reactions to the active ingredients of PD-1 monoclonal antibody or any excipients; 3. A history of other malignant tumors within 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma; 4. Symptomatic central nervous system metastasis; 5. Those who have received strong CYP3A4 inhibitor treatment within one week before enrollment, or have received strong CYP3A4 inducer treatment within 2 weeks before participating in the study; 6. The heart function classification of the New York Heart Association is III-IV congestive heart failure; an ischemic cardiovascular event occurred within 1 year before the start of treatment; 7. Be receiving systemic immunosuppressive therapy; 8. Participate in other interventional drug clinical trials within 4 weeks before the first administration; 9. Subjects who need to be given corticosteroids (more than 10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before using the study drug for the first time; 10. Have received an anti-tumor vaccine or have received a live vaccine within 4 weeks before the first administration of the study drug; underwent major surgery or severe trauma within 4 weeks before the first use of the study drug; 11. Severe infections (CTCAE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infectious complications that require hospitalization; 12. Baseline chest imaging examinations suggest the presence of active lung inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 13. Have active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, and type 1 diabetes with a stable dose of insulin can be included; but does not include vitiligo or cured childhood asthma/allergies , patients who do not need any intervention after adulthood; 14. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation; 15. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection but without formal treatment 1 year ago; 16. The subject has active hepatitis (HBV DNA >= 2000IU/ml or 10000 copies/ml), hepatitis C (hepatitis C antibody is positive, and the HCV-RNA is higher than the lower limit of the analysis method); 17. Known history of psychotropic drug abuse, alcohol abuse and drug abuse; 18. Pregnant or breastfeeding; 19. There is a medical history, disease, treatment, or abnormal laboratory results that may interfere with the test results and prevent the subject from participating in the research, or the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of remission;1 year overall survival;Adverse reactions; | — |
Countries
China
Contacts
Public ContactLi Zhiping
West China Hospital of Sichuan University
Outcome results
None listed