Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC

Inclusion Criteria

• •The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
• •Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent；
• •Histologically or cytologically confirmed, locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
• •ECOG score 0 or 1;
• •Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
• •Liver function met the following criteria within 7 days prior to initial administration:
• •Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
• •Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;
• •Life expectancy \>3 months;
• •The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol