Potentially Immunotherapy-Sensitive Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Immunomodulation group:Receiving neoadjuvant therapy with Rituximab-Trastuzumab combined with Rilapafusp-a.
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, can complete the signed informed consent form, and have good compliance; 2. Age 18-75 years old (at the time of signing the informed consent form), male or female; 3. Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, diagnosed with locally advanced stage according to AJCC 8th edition criteria, diagnosed with T3-4N M0 according to endoscopic ultrasound or enhanced CT/MRI scan (combined with diagnostic laparoscopic exploration if necessary) cTNM, and agreeing to undergo radical surgical treatment, with the lesion assessed by the investigator as potentially resectable; 4. No previous systemic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy, etc.; 5. Endoscopic biopsy tissue IHC results confirmed as HER2 IHC 3 or HER2 IHC 2 and FISH positive; 6. PD-L1 CPS >= 5, EBV positive, or dMMR/MSI-H: at least one of the three is met; 7. ECOG score of 0-1 points; 8. Expected survival >= 6 months; 9. Major organs are functioning well and meet the following criteria: (1) Routine blood examination (no blood transfusion within 7 days, no use of hematopoietic stimulating factor drugs to correct the state): hemoglobin (Hb) >= 80 g/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelets (PLT)> = 80 x 10^9/L; (2) Biochemical examination: 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) Doctors clinically judge to have adequate organ function. 10. Subjects of childbearing potential must use an adequate method of contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: 1. Combined with other malignant diseases other than gastric cancer (excluding radical early tumors); 2. Tumor lesions with bleeding tendency (such as active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, risk of gastrointestinal bleeding as judged by the investigator, etc.) or blood transfusion treatment 4 weeks before study drug use; 3. Currently participating in other interventional drug clinical investigational treatment, or receiving other investigational drugs or using investigational devices within 4 weeks before the first dose; 4. Previous treatment of the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 drugs, anti-PD-L2 drugs, or drugs targeting another stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 5. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Note: Physiologic doses of glucocorticoids (= grade 2; 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Subjects with active hepatitis B or hepatitis C; 12. Vaccination with live vaccine within 30 days before the first dose (Cycle 1, Day 1); Note: Receipt of injectable inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is allowed; However, it is not allowed to receive intranasal live attenuated influenza vaccine; 13. Pregnant or lactating women; 14. Presence of any serious or uncontrolled systemic disease such as: (1) Resting ECG with significant rhythm, conduction or morphological abnormalities with severe symptoms that are difficult to control, such as complete left bundle branch block, heart block of the second degree or above, ventricular arrhythmias or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade >= 2; (3) Any arterial thrombosis, embolism or ischemia within 6 months before enrollment in treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; (4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (5) History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year before the first dose, or current clinically active interstitial lung disease; (6) Active tuberculosis; (7) Presence of active or uncontrolled infection requiring systemic treatment; (8) Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; (9) Liver disease such as cirrhosis, decompensated liv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of AE Events to Total Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS (Event-Free Survival);R0 resection rate;Disease-free Survival (DFS);Complete pathological response (pCR) rate;OS (Overall Survival);Major Pathological Response (MPR); | — |
Countries
China
Contacts
Public ContactXu Hao
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed