Gastric Cancer
Conditions
Interventions
trail group: Disitamab vedotin+xindilimab+oxaliplatin+tigio (S-1)
Vediximab: 2.5 mg/kg, intravenous infusion, Q3W, Administer on the first day of each treatment cycle.
Xindilimab: 200 mg/time, intrave
Control group:Oxaliplatin and Tegio (S-1)
Oxaliplatin: 130mg/m2, intravenous drip, Q3W, Administer on the first day of each treatment cycle.
S-1: 40-60 mg/time, oral administration, bid,d1-14.
Every 3
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, were able to sign the informed consent form, and had good compliance; 2. Age >= 18 years old (when signing the informed consent form), regardless of gender; 3. Gastric cancer or gastroesophageal junction adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to AJCC 8th edition, diagnosed as cT3-4AN1-3M0 based on endoscopic ultrasound or enhanced CT/MRI scan (combined with endoscopic ultrasound and diagnostic laparoscopic exploration if necessary) cTNM, and evaluated by the researcher as resectable lesions; 4. Have not received systematic treatment for the current disease in the past, including surgical treatment, anti-tumor radiotherapy/chemotherapy/immunotherapy, etc; 5. Patients who agree to undergo radical surgery and have no surgical contraindications as determined by the surgeon; 6. IHC results confirmed high expression of HER-2 (defined as IHC 2+and 3+); 7. ECOG score 0-1 points; 8. Expected survival period >= 6 months; 9.Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) >= 90g/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 80 × 10^9/L; 10. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50%; 13. Renal function: Blood creatinine = 50 mL/min; Female: CrCl=(140 age x weight (kg) x 0.85/72 x serum creatinine (mg/dL) Male: CrCl=(140 age x weight (kg) x 1.00/72 x serum creatinine (mg/dL) 6) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 14. Able to understand the experimental requirements, willing and able to follow the experimental and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Prior to the start of drug administration, any anti-tumor treatment received for gastric cancer/gastroesophageal junction adenocarcinoma, including chemotherapy, radiation therapy, anti-HER-2, anti-PD-1/PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); And other anti-tumor drug treatments (including receiving traditional Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening), etc; 2. Active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening; Or gastrointestinal perforation/fistula within 6 months prior to screening; 3. Currently participating in interventional clinical research treatment, or having received other investigational drugs or undergone major surgery within 4 weeks before the first administration and not fully recovered; 4. Vaccination with a live vaccine within 4 weeks prior to screening or planning to receive any vaccine during the study period (note: administration of inactivated virus vaccine for seasonal influenza within 30 days prior to the first dose is allowed; however, intranasal administration of attenuated live influenza vaccine is not allowed); 5. Screening for active autoimmune diseases that require systemic treatment (such as the use of immunomodulatory drugs, corticosteroids, or immunosuppressants) within the previous 2 years, allowing for relevant alternative treatments (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary dysfunction), as well as a history of refractory autoimmune diseases. Systemic use of steroids (dose>10 mg/d prednisone or equivalent dose of other corticosteroids) or other systemic immunosuppressive therapies within 14 days prior to screening; 6. Screening for other malignant tumors within the previous 5 years, excluding those that have been cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma, or breast ductal carcinoma in situ treated with radical surgery); 7. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Individuals known to be allergic to any medication in this study; 9. Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or baseline, excluding fatigue or hair loss); 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can be included in the group: Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation; For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is required; 12. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 13. Pregn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;tumor regression grade;major pathological response;objective response rate;disease free survival ;overall survival; | — |
Countries
China
Contacts
Public ContactJie Chai
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed