Gastric cancer
Conditions
Interventions
A:Sindilimab + Decitabine + XELOX
B:Sindilimab + XELOX
C:Decitabine + XELOX
D:XELOX
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who signed the written informed consent before the implementation of any test related process; 2. Male or female, 18 years old 3 months; 7. Laboratory index: Blood routine: hemoglobin > 9g / dl, platelet >= 100 x 10^9/L, absolute neutrophil count (ANC) >= 1.5x10^9/l. Liver function: TBIL = 60 ml / min; Coagulation function: good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; Thyroid function: normal thyroid function, defined as thyroid stimulating hormone (TSH) in the 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; Myocardial enzyme spectrum: myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that there is no clinical significance of simple laboratory abnormality, it is also allowed to be included in the group); 8. For female subjects of childbearing age, the urine or serum pregnancy test should be conducted within 3 days before the first study drug administration (the first day of the first cycle) and the result is negative. If the urine pregnancy test results can not be confirmed as negative, blood pregnancy test is required. Women of non reproductive age were defined as postmenopausal for at least one year, or had undergone surgical sterilization or hysterectomy; 9. If there is a risk of pregnancy, all subjects (male or female) should take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. HER-2 positive patients; 2. Patients with known endoscopic signs of active bleeding of lesions; 3. Subjects who have received the following therapies in the past: surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; 4. Subjects who received Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration received systemic treatment; 5. Patients with active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy; 6. Study the patients who are receiving systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: physiological dose of Glucocorticoid (= 2; Patients who had any arterial thrombosis, embolism or ischemia within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc; Poor blood pressure control (systo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood count;Liver function;Renal function;Blood glucose;Electrolyte;Tumor markers;Coagulation function;Fibrinolysis function;Examination items before blood transfusion;Immunoassay;Myocardial enzymes;Myocardial injury markers;BNP;ASO, CRP, RF, ESR;TT3, TT4, FT3, FT4, TSH;TSH, TRH, ACTH, LH, GH, ADH, PRL, FSH;Head CT scan;Thoracic and abdomen CT scan + enhancement;Upper abdominal MRI;Color Doppler ultrasound of superficial lymph nodes;Echocardiography;ECG;Gastroscopy;Urine test;Stool examination + Occult blood;HCG (only female);HBV, HCV; | — |
Countries
China
Contacts
Public ContactJun Zhao
Changzhi People's Hospital
Outcome results
None listed