Gastric adenocarcinoma
Conditions
Interventions
intervention group :preoperative: Carrelizumab combined with DOX
postoperation:Carrelizumab combined with capecitabine
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 75 years, both male and female; 2. Patients with ECoG score of 0-2; 3. The patients with locally advanced gastric adenocarcinoma were diagnosed histologically; 4. It is expected that the patients in the group can tolerate the combined therapy and the survival period is more than 6 months; 5. According to the enhanced CT / MRI (combined with ultrasonic gastroscopy and diagnostic laparoscopy if necessary), the patients were divided into C stage II and stage III (t3-4a / N + M0, t3-4a / n-m0, AJCC 8th Edition ctnm); 6. R0 resection for patients who can complete radical D2 lymph node dissection (the number of lymph nodes to be examined must be at least 15 to ensure the quality of operation); 7. Patients with physical condition and organ function who are allowed to undergo major abdominal operations; 8. Patients with adequate organ bone marrow function are defined as follows: (1) Blood routine test: absolute neutrophil count (ANC) >= 1.5 * 10^9 / L; Platelet count (PLT) >= 100 * 10^9 / L; Hemoglobin content (Hgb) >= 9.0g/dl. (2) Liver function: patients without liver metastasis require serum TBIL = 50ml / min (calculated by Cockcroft / Gault formula): Female: CCR = (140 years old) * body weight (kg) * 0.85/72/serum creatinine (mg / dl); Male: CCR = (140 years old) * body weight (kg) * 1.00/72/serum creatinine (mg / dl). (4) The coagulation function is sufficient, defined as international standard ratio (INR) or prothrombin time (PT) = 50% confirmed by echocardiography; 10. Patients who voluntarily participated in the study, had good compliance, cooperated with safety and survival follow-up. 11. Provide written informed consent before entering the study screening, and the patient has understood that he can withdraw from the study at any time without any loss; 12. Subjects who agree to provide blood and histological specimens. 13. During the research and treatment period and within 3 months after the end of the research and treatment period, the female patients of non-surgical sterilization or childbearing age need to adopt a kind of contraceptive measure (such as IUD, contraceptive pill or condom) which is approved by medicine; the serum or urine HCG test of the female patients of non-surgical sterilization in childbearing age must be negative within 7 days before the research group; and they must be non lactation period; Male patients of non-surgical sterilization or childbearing age need to agree to use a medically recognized contraceptive measure with their spouses during the study treatment period and within 3 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who have received prior anti-tumor treatment, including chemotherapy and radiotherapy, targeted treatment or immunotherapy, etc.; 3. Patients with other malignant tumors in the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); 4. Patients with uncontrollable pleural effusion, pericardial effusion or ascites; 5. Patients with severe cardiovascular disease within 12 months before admission, such as symptomatic coronary heart disease, congestive heart failure >= grade II, uncontrolled arrhythmia, myocardial infarction; 6. Patients with upper respiratory tract obstruction / hemorrhage or digestive dysfunction or malabsorption syndrome; 7. Patients with severe uncontrolled concurrent infection or other uncontrolled concomitant diseases, moderate or severe renal injury; 8. Patients with allergic reactions to the drugs used in this study; 9. Patients who received steroid or other systemic immunosuppressive therapy 14 days before admission; 10. Patients receiving study drug treatment within 4 weeks before enrollment (participating in other clinical trials); 11. Patients with active autoimmune diseases; 12. Patients with a history of primary immunodeficiency; 13. Patients who have used immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding local glucocorticoids or systemic glucocorticoids (i.e. prednisone or other glucocorticoids of equivalent dose not more than 10mg / day) in nasal spray, inhalation or other ways, or hormone used to prevent allergy of contrast medium; 14. Patients receiving live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period; 15. Patients known to have active tuberculosis; 16. Patients with known history of allogeneic organ transplantation and integrated hematopoietic stem cell transplantation; 17. HIV positive, active hepatitis B or C (HBV, HCV) patients; 18. Subjects who cannot or do not agree to bear part of the cost of examination and treatment at their own expense, excluding clinical research drugs, combined chemotherapy and SAE related to clinical research drugs combined chemotherapy; 19. Subjects with a history of psychoactive substance abuse, alcoholism or drug abuse; 20. The researcher thinks that it should be excluded from the study. For example, according to the judgment of the researcher, there are other factors that may cause the study to be forced to terminate midway. For example, other serious diseases (including mental diseases) need to be treated together, there are serious laboratory examination abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;3 years OS;3 years DFS rate;DCR; | — |
Countries
China
Contacts
Public ContactXuewei Ding
Tianjin Cancer Hospital
Outcome results
None listed