Gastric Cancer
Conditions
Interventions
Sponsors
Cangzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. ECOG 0-1 points; 3. Histologically confirmed gastric adenocarcinoma without prior surgical treatment or antitumor chemoradiotherapy/immunotherapy; 4. Diagnosis of locally advanced stage according to the 8th edition of AJCC, cTNM diagnosis of cT3-4NXM0 according to endoscopic ultrasonography or enhanced CT/MRI scan, and the lesion is resectable; 5. Take contraceptive measures during the trial period; 6. The baseline blood routine and biochemical indicators of the selected patients should meet the following criteria: hemoglobin >= 90 g/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, aspartic acid or Alanine aminotransferase = 30 g/L, INR/PT <= 1.5 x ULN, APTT <= 1.5 x ULN; 7. Sign the informed consent form, have no other surgical contraindications, and agree to provide blood samples and histological specimens; 8. At least one measurable lesion according to RECISTv1.1.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age have a positive baseline pregnancy test; 3. Diagnosis of distant metastasis by CT/MR/EUS; 4. Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy; 5. Suffering from other malignant tumors (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) in the past 5 years; 6. Uncontrollable pleural effusion, pericardial effusion or ascites; 7. Severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure >= grade II, uncontrolled arrhythmia, myocardial infarction; concurrent upper gastrointestinal obstruction/bleeding or digestive function Abnormal or malabsorption syndromes; 8. Concurrent with severe uncontrolled concurrent infection or other severely uncontrolled concomitant diseases, moderate or severe renal impairment; 9. Allergic reactions to the drugs used in this study; 10. Using steroids or other systemic immunosuppressive therapy 14 days before enrollment; 11. Patients receiving study drug treatment within 4 weeks before enrollment (participating in other clinical trials); 12. Active autoimmune disease; 13. History of primary immunodeficiency; 14. Immunosuppressive drugs have been used within 4 weeks before the first dose of study treatment, excluding topical glucocorticoids by nasal spray, inhalation or other routes or systemic glucocorticoids at physiological doses (that is, no more than 10 mg/day) Nisone or other glucocorticoids at equivalent doses), or use of corticosteroids to prevent allergy to contrast media; 15. Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study; 16. Known to have active pulmonary tuberculosis; 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 18. HIV antibody positive, active hepatitis B or C (HBV, HCV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The major pathological remission rate;Tumor regression grade;R0 resection rate;Postoperative complication;The occurrence of adverse reactions;Tumor volume changes after neoadjuvant therapy;Disease free survival time (DFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactGuoda Han
Cangzhou Central Hospital
Outcome results
None listed