Gastric cancer
Conditions
Interventions
Cohort1: Localized late stage:Tislelizumab combined with albumin paclitaxel and S-1
Cohort2: Liver metastasis:Tislelizumab combined with albumin paclitaxel and S-1
Sponsors
The First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the study and sign the informed consent; 2. Aged 18-70 years (calculated on the day of signing the informed consent), both male and female; 3. Advanced gastric adenocarcinoma confirmed by histology/cytology and HER-2 negative by IHC/FISH (HER2 positive definition: HER2 IHC 2+/FISH positive, or IHC 3+, excluding IHC 0 or 1+/ FISH positive; 4. Have not received any disease-related treatment (including but not limited to radiotherapy, chemotherapy, targeted therapy and immunotherapy); 5. ECOG score: 0-1 points; 6. According to RECIST v1.1 criteria, there is at least 1 evaluable lesion; 7. Good heart function, no myocardial infarction in the past six months, controllable hypertension and other coronary heart disease, and no serious infection; 8. Vital organ functions meet the following requirements: (1) Absolute neutrophil count >= 1.5 x 10^9/L; (2) White blood cells >= 4.0 x 10^9/L; (3) Platelets >= 90 x 10^9/L; (4) Hemoglobin >= 80 g/L; (5) Serum albumin >= 30 g/L; (6) Thyroid-stimulating hormone (TSH) <= 1×ULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be included); (7) Serum total bilirubin <= 1 x ULN; (8) ALT and AST <= 3 x ULN; (9) AKP <= 2.5 x ULN (with known bone metastases <= 5 x ULN); (10) Serum creatinine <= 1.5 x ULN; 9. Non-surgical sterilization or female subjects of childbearing age who need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 180 days after the end of the study treatment period; Female subjects of childbearing age who have undergone surgical sterilization must have a negative serum HCG test within 72 hours before screening; and must be non-lactating; for male subjects whose partners are women of childbearing age, the study treatment period and the end of the study treatment period Use an effective method of contraception for the next 180 days.
Exclusion criteria
Exclusion criteria: 1. With any active, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type 1 diabetes mellitus receiving stable doses of insulin, hypothyroidism requiring only hormone replacement therapy, no systemic therapy required, and no acute exacerbation of skin disease (eg, eczema, vitiligo, or psoriasis) within 1 year prior to the screening period; 2. Subjects who have used corticosteroids (>10 days of prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before screening. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone 1.5 or prothrombin time (PT) > ULN + 4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulant therapy, low-dose aspirin and low-molecular-weight heparin are allowed to be used prophylactically; 13. Suffering from active infection or unexplained fever of 38.5 ? within 7 days before administration, or baseline white blood cell count > 15 x 10^9/L; 14. Suffering from congenital or acquired immunodeficiency (such as HIV infection); or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA 500 IU/mL; hepatitis C reference HCV antibody positive and HCV virus copy number upper limit of normal value); 15. Suffering from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 16. Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study; 17. According to the investigat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Progression Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLisong Teng
The First Affiliated Hospital of Zhejiang University
Outcome results
None listed