Gastric Cancer
Conditions
Interventions
Intervention Group:The intervention consists of four phases: neoadjuvant therapy combined with radiotherapy, surgery, adjuvant therapy, and maintenance therapy.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study, are able to sign the informed consent form, and demonstrate good compliance; 2. Aged 18-75 years (at the time of signing informed consent), both males and females are eligible; 3. Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, diagnosed as locally advanced according to AJCC 8th edition criteria. Based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (supplemented by diagnostic laparoscopy if necessary), cTNM staging must be cT1-2N1-3M0 or cT3-4aN0-3M0. Subjects must agree to undergo radical surgery, and the investigator must assess the lesion as resectable; 4. No prior systemic therapy for the current disease, including anticancer radiotherapy, chemotherapy, immunotherapy, etc.; 5. Immunohistochemistry (IHC) confirms HER2 overexpression (defined as IHC 2+ or 3+); 6. ECOG score of 0-1; 7. Expected survival period >=6 months; 8. Adequate major organ function, meeting the following criteria: (1) Hematological tests (without transfusion or hematopoietic growth factor correction within 14 days): Hemoglobin (Hb) >=90 g/L; Absolute Neutrophil Count (ANC) >=1.5×10?/L; Platelets (PLT) >=80×10?/L; (2) Biochemical tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =60 mL/min; (3) Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) =50%; (5) Clinically assessed by the physician as having adequate organ function. 9. Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must not be lactating.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of malignancies other than gastric cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2. Tumor lesions with bleeding tendency (e.g., presence of active ulcerated tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing informed consent, or judged by the investigator to be at risk of major gastrointestinal bleeding, etc.) or having received blood transfusion within 4 weeks prior to study treatment; 3. Inability to take oral medication; 4. Current participation in interventional clinical study treatment, or having received other investigational drugs or device therapy within 4 weeks before the first dose; 5. Prior treatment with any of the following: anti-HER2, anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 6. Systemic treatment with Chinese proprietary medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 8. Systemic corticosteroid therapy (excluding nasal spray, inhaled, or other routes of local corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first dose; Note: physiologic doses of corticosteroids (= Grade 2; 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13. Active hepatitis B or hepatitis C (HBsAg positive with HBV DNA titer above the upper limit of normal; HCVAb positive with HCV RNA titer above the upper limit of normal); 14. Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: inactivated seasonal influenza vaccines administered by injection are allowed within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted; 15. Pregnant or lactating women; 16. Presence of any severe or uncontrolled systemic disease, such as: (1) Resting ECG showing significant and symptomatic abnormalities in rhythm, conduction, or morphology that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class >= 2; (3) Any arterial thrombosis, embolism, or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Poorly controlled blood pressure (systolic blood pressure >140 mmHg, diasto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response rate;objective response rate;disease control rate;R0 resection rate;progression-free survival;2-year overall survival rate; | — |
Countries
China
Contacts
Public ContactSun Yan
Jiangsu Cancer Hospital
Outcome results
None listed