Locally Advanced Gastric Cancer with Low-to-Intermediate HER2 Expression
Conditions
Interventions
Experimental group:Disitamab Vedotin and Serplulimab and Oxaliplatin and S-1
Control group:Oxaliplatin and S-1
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form. (1) Subjects must sign and date the IRB/IEC-approved informed consent form according to the guidelines of the competent authorities and research institutions. The informed consent form must be signed before any protocol-related procedures are performed (parts that are not part of the subject's routine medical care). (2) Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study. 2. Age >=18 years and =6 months. 5. Tumor staging follows the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) TNM classification, with histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, clinical stage II or III patients (cT3/T4a, or N, M0). 6. HER2 testing IHC result of 1 or 2, and at the time of signing the informed consent, known FISH status is excluded. 7. No prior systemic anti-tumor treatment, such as chemotherapy or radiotherapy. 8. Consent at enrollment to obtain tumor tissue and blood specimens both at baseline and after treatment surgery. 9. Subjects’ blood routine and biochemical indicators meet the following criteria: hemoglobin =80 g/L; absolute neutrophil count (ANC) >=1.5×10^9/L; platelets >=100×10^9/L; ALT, AST =30 g/L; international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <=1.5 times the upper limit of normal. 10. No known dMMR/MSI-H status at the time of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Individuals with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders, where the researcher judges whether the clinical severity may interfere with compliance with the informed consent. 3. HER2 testing IHC result of 3+. 4. History of other malignancies within the past 5 years, except those that are cured or inactive. 5. Clinically significant (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe arrhythmias requiring medication intervention, or a history of myocardial infarction within the last 6 months. 6. Hypertension that cannot be controlled with medication, history of hypertensive crisis or hypertensive encephalopathy. 7. History of cerebral infarction or cerebral hemorrhage within the last 6 months. 8. Previous organ transplant or allogeneic hematopoietic stem cell transplant requiring immunosuppressive therapy. 9. Emergency surgery required due to tumor-related emergencies (bleeding, perforation, obstruction). 10. Pulmonary function test FEV1 < 50% of expected value. 11. Received investigational drugs, formulations, or treatments within 4 weeks before the first treatment (i.e., participation in other trials). 12. Underwent major surgery within 28 days prior to the initial administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Overall survival;Major Pathologic Response;R0 resection rate;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhenning Wang
The First Affiliated Hospital of China Medical University
Outcome results
None listed