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. Age 18-75 on the day of signing the informed consent; ECOG score 0-2; Child Pugh A grade; 4. According to the version 1.1 of the efficacy evaluation standard for solid tumors (RECIST v1.1), there are at least >=1 measurable lesions, or >=1 measurable lesions with clear progress after local treatment (based on the RECIST v1.1 standard); at the same time; Have >=1 radiotherapy lesions and lesions that can be assessed for distant effects by imaging; 5. Life expectancy >= 12 weeks; 6. Controlled subjects with hepatitis B need to meet the following criteria to be eligible to participate in the study: (1) You must have received HBV antiviral therapy for at least 1 month before the first administration of the study drug, and the HBV viral load before the first administration must be less than 2000 IU/mL (104 copies/mL). (2) Subjects who are receiving anti-HBV treatment with a viral load of less than 2000 IU/mL (10^4 copies/mL) should maintain the same treatment throughout the study treatment period. The function of major organs meets the following criteria within 28 days before treatment: 1) Routine blood test standards (without blood transfusion within 14 days): hemoglobin (HB) >= 80g/L; absolute value of neutrophils (ANC) >=1.5 x 10^9g/L; platelets (PLT) >= 80 x 10 ^9g/L; 2) Biochemical examinations must 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; activated partial thromboplastin time (APTT) <= 1.5 ULN (if the patient is receiving anticoagulation therapy, as long as PT and APTT are within the expected treatment range); 7. Thyroid function: T3 and T4 levels are normal after drug treatment; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine contraceptive 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 the study is enrolled; 9. With my consent and signed informed consent.
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; Have a history of other malignant tumors within 3.5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma; symptomatic central nervous system metastasis; 4. 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; 5. 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; 6. Are receiving systemic immunosuppressive therapy; 7. Participate in clinical trials of other intervention drugs within 4 weeks before the first administration; patients 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 the first use of study drugs Test subjects; have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug; received major surgery or severe trauma within 4 weeks before the first use of the study drug; severe cases occurred within 4 weeks before the first use of the study drug Infection (CTCAE greater than grade 2), such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization; 8. 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); active History of autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and comprehensive disease); 9. Autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone can be included in the use of a stable dose of insulin and type 1 diabetes; but does not include vitiligo or cured childhood asthma/allergies, and no need for adulthood Intervention patients; 10. Have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation; have active pulmonary tuberculosis infection through medical history or CT examination, or be enrolled in the group Patients with a history of active tuberculosis infection in the previous year, or patients with a history of active tuberculosis infection in the previous year but without formal treatment; the subject has active hepatitis (HBV DNA>=2000IU/ml or 10000 copies/ ml), hepatitis C (anti-hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method); known to have a history of psychotropic drug abuse, alcohol and drug abuse; currently pregnant or breast-feeding; 11. There are 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 researcher believes
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