The enrolled patients are gastric cancer confirmed by pathology, with clinical stage II (cT3-4N0M0 or cT1-3N1-3M0) or III (cT3-4AN1-3M0) esophagogastric junction tumors, and clinical stage III (cT3-4AN1-3M0) non esophagogastric junction tumors without distant metastasis (M0).
Conditions
Interventions
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. I have fully understood and voluntarily signed the informed consent form for this study; Willing and able to comply with the research plan during the study period; 2. Gastric cancer confirmed by pathology and meeting the following criteria: esophagogastric junction tumor with clinical stage II (cT3-4N0M0 or cT1-3N1-3M0) or III (cT3-4aN1-3M0), and non esophagogastric junction tumor with clinical stage III (cT3-4aN1-3M0); No distant metastasis (M0); 3. Age >= 18 years old, gender not limited, ECOG score 0-2 points; 4. The physical condition and organ function allow for larger abdominal surgeries; 5. Agree to allow researchers to use blood, feces, and pathological sections for research during the study period; 6. The main organ functions meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards): (1) Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor, no use of medication correction within 14 days before screening): 1) Neutrophils >= 1.5 × 10^9/L; 2) Platelets >= 75 × 10^9/L; 3) Hemoglobin >= 90g/L; (2) Biochemical examination: (No albumin transfusion within 14 days before screening): 1) Blood creatinine 50 mL/min; 2) Serum total bilirubin <= 1.5 × ULN; c) Aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN; (3) Coagulation function: 1) International normalized ratio (INR) <= 2.3 or prothrombin time (PT) exceeding the normal control range <= 6 seconds;
Exclusion criteria
Exclusion criteria: 1.The tumor has distant metastasis or peritoneal metastasis confirmed by laparoscopy; 2.Patients with other severe immunosuppressive diseases or concurrent malignant tumors; 3.There are any conditions that affect the absorption of capecitabine in the gastrointestinal tract; 4.Severe uncontrolled recurrent infections, or other serious uncontrolled accompanying diseases; Serious mental illness; Serious respiratory system diseases; Severe liver and kidney dysfunction; History of unstable angina or myocardial infarction within 6 months; History of cerebral infarction or cerebral hemorrhage within 6 months; Continuous use of glucocorticoids within one month (excluding local application); 5.Researchers have identified patients with other comorbidities that pose a risk to patient safety or may affect the completion of the study; 6.Currently or previously received any other investigational medication or immunotherapy; 7.Suffering from malignant tumors in other parts of the body within five years;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Disease control rate;Complete surgical resection rate;Clinical decline rate (T and/or N decline);Objective Response Rate; | — |
Countries
China
Contacts
Public ContactLi Yongxiang
The first affiliated hospital of anhui medical university
Outcome results
None listed