PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

Exclusion Criteria

• •1. Patients with a history of severe hypersensitivity to other monoclonal antibodies or any component of toripalimab injection (JS001).
• •2. Preoperative pathology diagnosed as squamous cell carcinoma or neuroendocrine tumor.
• •3. Patients have experienced or currently have other malignancies within 5 years.
• •4. Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
• •5. Patients with history of autoimmune disease; patients with autoimmune-related hypothyroidism receive stable doses of thyroid hormone replacement therapy Eligible to participate in this study; Type 1 diabetes patients who are controlled after receiving a stable insulin treatment plan are eligible to participate in this study;
• •6. Patients have received systemic immunostimulatory drug therapy (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is shorter);
• •7. Patients who have undergone allogeneic bone marrow transplantation or solid organ transplantation in the past;
• •8. Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical routines), hepatitis B {known HBV surface antigen (HBsAg) positive, and HBV DNA ≥1000cps/ml}, hepatitis C or human immunodeficiency virus (HIV antibody positive).
• •9. Patients with previous or cured HBV infection (defined as hepatitis B core antibody \[anti-HBc\] positive and HbsAg negative) are only eligible to participate in this study when HBV DNA is negative (HBV DNA ˂1000cps/ml).
• •10. Patients with positive hepatitis C (HCV) antibodies are only eligible to participate in this study if the polymerase chain reaction shows negative HCV RNA.
• •11. There is a serious neurological or mental illness, including dementia and seizures.
• •12. Suffer from NCI-CTCAE ≥ Grade 2 peripheral neuropathy.
• •13. Women who are pregnant or breastfeeding.
• •14. Chronic bowel disease or short bowel syndrome.
• •15. Those who are deficient in the enzyme dihydropyrimidine dehydrogenase (DPD).
• •16. Major cardiovascular diseases, such as New York Heart Association heart disease (level II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, or unstable angina.
• •17. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If necessary, you can consult a cardiologist.