liver cancer
Conditions
Interventions
Intermediate and high recurrence risk group after liver cancer operation:Anti-pd-1 therapy
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any test-related procedures; 2. Aged >= 18 and = 1.5 x 10^9/l without using granulocyte colony stimulating factor in recent 14 days. 2) under the condition of no blood transfusion in recent 14 days, platelet >= 50 x 10^9/l. 3) Hemoglobin > 9g/dl without blood transfusion or erythropoietin in recent 14 days; 4) Total bilirubin = 60 ml/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 8) Normal thyroid function is defined as thyroid-stimulating hormone (TSH) in normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. 9) The myocardial enzyme spectrum is within the normal range; 10. Female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before the first study drug administration (the first day of the first cycle), and the result is negative. If urine pregnancy test results cannot be confirmed as negative, blood pregnancy test is required. Non-childbearing age women are defined as at least one year after menopause, or have undergone surgical sterilization or hysterectomy; If there is a pregnancy risk, all subjects (male or female) should use contraception with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. Major surgical treatment has been performed within 3 weeks of treatment (except surgery for biopsy); 2. Diagnosed as other malignant diseases besides HCC within 5 years before treatment (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection of carcinoma in situ); 3. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first treatment; 4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA-4, OX-40 and CD137); 5. Received anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks before the first treatment; 6. Active autoimmune diseases requiring systemic treatment (for example, using disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first treatment. Substitution therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary dysfunction, etc.) is not regarded as systemic treatment; 7. The study is receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoid) or any other form of immunosuppressive therapy within 7 days before the first treatment; Note: It is allowed to use physiological dose of glucocorticoid (= 2; 3) Myocardial infarction occurred within 6 months before randomizati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival, RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;Incidence of SAE; | — |
Countries
China
Contacts
Public ContactZhang Yonghong
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed