gastric cancer
Conditions
Interventions
Observation group:None
Sponsors
Xingtai People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years and = 12 weeks; 7.Adequate major organ function, meeting the following criteria (within 14 days prior to enrollment): (1) Hematology: a. Hemoglobin >= 90 g/L; b. Absolute neutrophil count >= 1.5×10^9/L; c. Platelet count >= 100×10^9/L; (2) Biochemistry: a. Serum albumin >= 30 g/L; b. ALT and AST = 50 mL/min; 8.The subject voluntarily participates in the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with a known hypersensitivity to the investigational drug; 2.Subjects with any active, known, or suspected autoimmune disease; 3.Subjects who have received systemic treatment with corticosteroids (prednisone or equivalent >10 days) or other immunosuppressants within 1 month prior to screening; 4.Subjects who have undergone major surgery (excluding diagnostic procedures) within 4 weeks before the start of study treatment or are expected to require major surgery during the study period; 5.Subjects unable to swallow tablets, with malabsorption syndrome, or any condition affecting gastrointestinal absorption; 6.Subjects with severe cardiac disease or discomfort, including but not limited to the following conditions: (1) A confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block); (3) Angina requiring anti-anginal medication; (4) Clinically significant valvular heart disease; (5) ECG evidence of transmural myocardial infarction; (6) Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 7.Active hepatitis (for hepatitis B: HBsAg-positive with HBV DNA >= 2000 IU/ml; for hepatitis C: HCV antibody-positive with HCV viral load above the upper limit of normal); 8.Subjects with active infection or unexplained fever > 38.5°C within 2 weeks before the first dose (fever caused by the tumor itself may be allowed at the investigator’s discretion); 9.Subjects who may receive vaccinations during the study period; 10.Pregnant or breastfeeding women; 11.Any other condition that, in the investigator’s judgment, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-free survival;1-year overall survival rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactGuo Jun
Xingtai People's Hospital
Outcome results
None listed