Gastric cancer
Conditions
Interventions
Cindilimab combined with XELOX regimen:Cindilimab combined with XELOX regimen
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any test-related process; 2. Male or female, age >= 18 years old; 3. Histologically confirmed gastric adenocarcinoma was diagnosed as locally advanced according to AJCC version 8, and cT3-4aN1-3M0 according to endoscopy or enhanced CT scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary), and the investigator evaluated that the lesion could be resected; 4. Have not received systematic treatment for current diseases in the past, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc; 5. Patients who agree to receive radical surgery and are judged by surgeons to have no surgical contraindications 6. ECoG score: 0-1; 7. Expected survival time > 6 months; 8. For sufficient organ function, the subject shall meet the following laboratory indexes: (1) The absolute value of neutrophils (ANC) >= 1.5*10^9/L without granulocyte colony-stimulating factor in recent 14 days; (2) Platelets >= 100 without blood transfusion in recent 14 days × 109/L (3) Hemoglobin > 9g/dL without blood transfusion or erythropoietin in recent 14 days; (4) Total bilirubin 1.5*ULN but direct bilirubin = 60 ml/min; (7) Good coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Thyroid stimulating hormone (TSH) is defined as normal thyroid function. 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 (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group); 9. For female subjects of childbearing age, urine or serum pregnancy test shall be conducted within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as having been postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects (male or female) are required to use contraceptives with an annual failure rate of less than 1% throughout the 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. Other malignant diseases other than gastric cancer diagnosed within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radical resection of carcinoma in situ); 2. The signs of active bleeding of the focus are known to be displayed under endoscopy; 3. Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 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 (including but not limited to CTLA-4, OX-40, CD137, etc.); 5. Have received systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 6. Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 7. Being treated with systemic glucocorticoids (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: it is allowed to use glucocorticoids in physiological doses (<= 10 mg/day prednisone or equivalent); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. People who are known to be allergic to the drugs used in this study; 10. Those with multiple factors affecting capecitabine (such as inability to swallow and intestinal obstruction); 11. Has not fully recovered from the toxicity and/or complications caused by any intervention before starting treatment (i.e. <= grade 1 or reaching baseline, excluding fatigue or hair loss); 12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center): Note: hepatitis B patients who meet the following criteria can also be enrolled: (1) Before the first administration, the HBV viral load was < 1000 copies/ml (200 IU / ml). Subjects should receive anti-HBV treatment throughout the study and chemotherapy treatment to avoid virus reactivation; (2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), preventive anti-HBV treatment is not required, but virus reactivation needs to be closely monitored; 14. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 15. Have received live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed 16. Pregnant or lactating women; 17. There are any serious or un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Disease free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Pathologic Complete Response;PD-L1; | — |
Countries
China
Contacts
Public ContactDan Li
Henan Provincial People's Hospital
Outcome results
None listed