Study of Perioperative Chemotherapy Combined With Tislelizumab and Trastuzumab in the Treatment of GC/EGC

Exclusion Criteria

• •A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)
• •Received other unmarketed investigational drug or therapy within 4 weeks prior to initial investigational drug use.
• •A major organ surgery (excluding needle biopsy) or significant trauma occurred within 4 weeks prior to initial investigational drug use.
• •Requires systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.
• •Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled glucocorticoids;Short-term use of glucocorticoids for preventive treatment (e.g. to prevent contrast allergy)
• •Use of immunoregulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to initial use of the study drug.
• •Has been administered a live vaccine within 4 weeks prior to Cycle1 Day 1.
• •Previous recipient of allogeneic hematopoietic stem cell transplantation or organ transplantation.
• •Previous adverse reactions to other medications have not recovered to CTCAE 5.0 level ≤1 (Other toxicities, such as hair loss, were not considered to pose a safety risk).
• •Symptomatic peripheral neuropathy was evaluated as \> 2 with CTCAE 5.0.
• •Has central nervous system metastases or meningeal metastases.
• •Inability to swallow medications orally, or other gastrointestinal diseases (such as total intestinal obstruction, etc.) that may affect the absorption of oral medications.
• •Patients who had an active infection within 1 week prior to the first use of the study drug and who currently require systemic anti-infective therapy.
• •has a history of alcohol or drug abuse or dependence.
• •Known history of Human Immunodeficiency Virus (HIV).
• •Untreated chronic hepatitis B viral (HBV) infection or chronic HBV carrier with HBV DNA ≥200 IU/mL (or 1000 copies/mL),prophylaxis antiviral therapy other than interferon is allowed ,or active hepatitis C virus (HCV) should be excluded.
• •Current patients with interstitial lung disease.
• •Has a history of severe cardiovascular and cerebrovascular disease, including but not limited to: has serious heart rhythm or abnormal conduction;Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months prior to D1 ;New York heart association (NYHA), cardiac function class II or higher and left ventricular ejection fraction (LVEF) \< 50%; clinical uncontrol of high blood pressure.
• •Patients with active, or previous and recurrent autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) were excluded from patients with clinically stable autoimmune thyroid disease.
• •Grade 3 or higher arteriovenous thromboembolism events or bleeding events occurred within 6 months prior to the first use of the study drug;Or present with grade ≥2 bleeding or factors determined by the investigator to have a higher blood risk (such as active gastrointestinal ulcer or esophageal varicose veins or tumor invasion of major blood vessels).
• •Gastrointestinal perforation, abdominal fistula or intraperitoneal abscess occurred within 6 months prior to the first use of the study drug;Or a risk factor for cavity perforation/fistula formation (e.g., tumor infiltration of the outer wall of the cavity wall) currently identified by the investigator.
• •Patients who allergies to the study drugs.
• •People with mental disorders or poor compliance.
• •Women who are pregnant or lactating.
• •The investigator considers the subject to have a history of other serious systemic disease or for other reasons unsuitable for participation in this clinical study.