Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

Exclusion Criteria

• •Patients with a history of (within the past 5 years) or current active malignancies. However, patients with cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, stage I colorectal cancer, etc., are eligible.
• •A history of upper abdominal surgery (except for laparoscopic cholecystectomy).
• •A history of gastric resection, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
• •Patients requiring surgery for other diseases concurrently.
• •Emergency surgery performed due to complications of gastric cancer (e.g., bleeding, obstruction, or perforation).
• •Patients preparing for or with a history of organ or bone marrow transplantation.
• •Blood transfusion within 2 weeks prior to surgery or a history of bleeding disorders, or any severe bleeding event (grade 3 or above according to CTCAE 4.0) occurring within 4 weeks prior to surgery.
• •Coagulation disorders or bleeding tendencies (INR \> 1.5 without anticoagulant use); patients receiving anticoagulants or vitamin K antagonists, such as warfarin, heparin, or similar agents. Low-dose warfarin (1 mg oral daily) or low-dose aspirin (≤100 mg daily) may be allowed for preventive purposes, provided the prothrombin time international normalized ratio (INR) is ≤ 1.5.
• •History of thromboembolic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening. Patients with venous thrombosis caused by prior chemotherapy and deemed healed by the investigator are excluded.
• •Myocardial infarction, poorly controlled arrhythmias (including QTc interval \> 450 ms for males and \> 470 ms for females) within 6 months prior to surgery. QTc interval should be calculated using the Fridericia formula.
• •NYHA class III or IV heart failure, or left ventricular ejection fraction (LVEF) \< 50% as per echocardiogram.
• •Pulmonary dysfunction with FEV1 \< 50% of predicted value.
• •Urinary protein ≥++ on routine urinalysis, confirmed by 24-hour urinary protein quantification \> 1.0 g.
• •Clinically symptomatic pleural effusion or ascites requiring clinical intervention.
• •Human immunodeficiency virus (HIV) infection.
• •Active pulmonary tuberculosis.
• •Chronic non-healing wounds or fractures with incomplete healing.
• •History of interstitial lung disease, pneumoconiosis, radiation-induced pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction that may interfere with the detection or management of potential drug-related pulmonary toxicity.
• •Known active or suspected autoimmune diseases, except those in stable condition at enrollment and without the need for systemic immunosuppressive therapy.
• •Severe chronic autoimmune diseases, such as systemic lupus erythematosus, inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease), chronic diarrhea syndromes (e.g., irritable bowel syndrome), sarcoidosis, or tuberculosis. Active hepatitis B or C or HIV infections. Non-severe autoimmune conditions, such as controlled psoriasis, dermatitis, or arthritis, are eligible. Patients with hepatitis B virus (HBV) with a viral load \< 500 copies/ml may be included.
• •Patients who require systemic corticosteroid treatment (\> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to surgery or during the study period. However, the following are allowed for inclusion: patients without active autoimmune diseases may use topical or inhaled steroids or adrenal hormone replacement therapy with a dose ≤ 10 mg/day prednisone equivalent.
• •Patients who have an active infection requiring systemic antibiotic treatment within 14 days prior to surgery (excluding those receiving prophylactic antibiotics for conditions like urinary tract infections or chronic obstructive pulmonary disease).
• •Patients who have received live vaccines within 28 days prior to surgery; seasonal influenza vaccination with inactivated viral vaccines is excluded.
• •Patients currently enrolled in another clinical trial involving surgery-related treatments.
• •Patients with a history of alcoholism, drug abuse, or substance misuse. Patients who have stopped drinking alcohol are eligible.
• •Patients who do not comply with medical instructions, fail to follow prescribed medication regimens, or have incomplete data that could impact the assessment of efficacy or safety.
• •Pregnant or breastfeeding female patients.
• •Patients with conditions that may increase the risks of participating in the study or with other severe, acute, or chronic diseases deemed by the investigator to be unsuitable for participation.
• •Other situations determined by the investigator that make the patient unsuitable for this clinical trial.