A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
• Voluntarily participate and sign the informed consent form;
• Male or female, ≥18 years;
• Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
• Clinical stage cT3-4aN+, no distant metastasis (M0);
• According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma;
• HER2- expression: IHC 1+, 2+, 3+;
• ECOG performance status score of 0 or 1;
• Cardiac function: left ventricular ejection fraction ≥50%;
• The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center):
‣ 1Bone marrow function:
‣ absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination);
‣ Platelets ≥100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks)
‣ hemoglobin ≥9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination);
‣ 2Liver function:
‣ Serum total bilirubin ≤1.5 times the upper limit of normal (ULN);
‣ alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN;
‣ 3 Kidney function:
• a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min according to Cockcroft-Gault formula method; Female: CrCl= (140-age) × weight (kg) × 0.85 72 × serum creatinine (mg/dL) Male: CrCl= (140-age) × weight (kg) × 1.00 72 × serum creatinine (mg/dL)
‣ 4 Coagulation function:
‣ prothrombin time (PT) ≤1.5×ULN;
‣ thrombin time (TT) ≤ 1.5×ULN;
‣ activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
⁃ Female subjects should be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device, contraceptives, or condoms) for 7 days before the first dose and for 6 months after the end of the study treatment period, and not breastfeed. Blood pregnancy tests must be negative within 7 days prior to study enrollment. Male subjects should agree to use at least one medically approved contraceptive method (e.g., condoms, abstinence, etc.) for 7 days prior to initial dosing and up to 6 months after the end of the study treatment period;
⁃ Able to understand trial requirements, willing and able to follow trial and follow-up procedures.