gastric cancer
Conditions
Interventions
Intervention group:Adebrelimab in combination with the XELOX or SOX regimen
Sponsors
Shandong Provincial Qianfoshan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed resectable gastric and gastroesophageal junction adenocarcinoma, staged as cT1N1-3M0 or cT2-4NanyM0; 2. No prior systemic anti-tumor therapy or surgical history for gastric or gastroesophageal junction adenocarcinoma; 3. Male or female patients aged 18 years or older; 4. ECOG performance status score of 0-1; 5. Expected survival of at least 3 months; 6. Normal bone marrow, liver, and kidney function; 7. Baseline echocardiography showing left ventricular ejection fraction (LVEF) >50%; 8. For women of childbearing potential, a pregnancy test within 14 days prior to the start of study treatment must be negative; 9. For women of childbearing potential or male patients, agreement to use effective contraception (e.g., abstinence, intrauterine device, oral contraceptives, or dual barrier method); 10. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pleural effusion, ascites, or pericardial effusion that requires drainage due to clinical symptoms; 2. A history of allergy to any component of adebrelimab, oxaliplatin, capecitabine, or tegio; 3. Any life-threatening bleeding event within the past 3 months, including those requiring blood transfusion, surgery or local therapy, or ongoing medication treatment; 4. Venous or arterial thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic history. Excludes catheter-related or superficial vein thrombosis if stabilized after routine anticoagulation treatment. Prophylactic use of low-dose low molecular weight heparin (such as enoxaparin 40 mg/day) is allowed; 5. Continuous use of aspirin (>325 mg/day) or other known platelet function inhibitors such as dipyridamole or clopidogrel for 10 days within 2 weeks prior to the first dose; 6. Uncontrolled hypertension, with systolic pressure >150mmHg or diastolic pressure >90mmHg after optimal medical therapy, history of hypertensive crisis or hypertensive encephalopathy; 7. Symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome, or QTc >500 ms at screening (calculated using the Fridericia method); 8. Severe bleeding tendency or coagulation disorders, or currently undergoing thrombolytic therapy; 9. History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within the past 6 months; 10. Radiation therapy within 3 weeks prior to the first dose. Patients who received radiation therapy more than 3 weeks prior to the first dose must meet all of the following conditions: no current radiation-related toxic reactions, no need for corticosteroids, and exclusion of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.; 11. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe impairment of pulmonary function, or other severe pulmonary diseases. 12. Active tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to the first dose; 13. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; 14. Severe infection in the active stage or with poor clinical control. Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization due to infections, bacteremia, or severe pneumonia complications; 15. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies are allowed (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency). Known history of primary immunodeficiency; 16. Patients with only positive autoimmune antibodies need confirmation by the investigator to determine if an autoimmune disease is present; 17. Use of immunosuppressive drugs within 4 weeks pri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactLiang Jing
Shandong Provincial Qianfoshan Hospital
Outcome results
None listed