Advanced gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Chemotherapy combined with immunotherapy group:Oxaliplatin in combination with capecitabine + Eppalolitovolizumab or Oxaliplatin in combination with Tegio + Eppalolitovolizumab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in this study, signed the informed consent form, and had good compliance; 2. Age>=18 years old, =12 weeks; 8. PD-L1 CPS=90 g/L b. Absolute neutrophil count >=1.5×10^9/L c. Platelets >=100×10^9/L; 2) Biochemical examination: a. Serum albumin>=30 g/L; b. ALT and AST=50 mL/min;
Exclusion criteria
Exclusion criteria: 1. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis; 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or drugs targeting another co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137); 3. Major surgical treatment (other than diagnosis) within 4 weeks prior to initiation of study treatment or anticipated need for major surgical treatment during the study; 4. Inability to swallow tablets, malabsorption syndrome, or any condition that affects gastrointestinal absorption; 5. Severe heart disease or discomfort, including but not limited to the following: --History of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block) --Angina pectoris requiring antianginal medication --Clinically significant valvular heart disease --ECG shows transmural myocardial infarction --Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 6. Have an autoimmune disease or other disease that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy with adrenal or pituitary insufficiency is allowed); 7. History of primary or acquired immunodeficiency (including allogeneic organ transplantation); 8. Pregnant and lactating females; 9. Patients with congenital or acquired immunodeficiency (such as HIV infection); 10. Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA =2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV viral copy number >upper limit of normal); 11. Have active infection or fever of unknown cause within 2 weeks before the first dose> 38.5°C (as judged by the investigator, the patient can be enrolled due to the fever caused by the tumor); 12. Has a severe concomitant disease or other comorbid disease that would interfere with the planned treatment, or any other condition that, in the opinion of the investigator, the patient is not suitable to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Disease Control Rate;Duration of Overall Response;Overall survival;Quality of Life Score; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactHe Wei/Liu Tao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed