gastric cancer
Conditions
Interventions
patient group:immunotherapy
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to participate in this study and signed informed consent; 2. Male or female, aged =18 years; 3.ECOG PS score 0-2; 4. Gastric/gastroesophageal junction adenocarcinoma confirmed by pathology; 5. External measurable lesions (RECIST 1.1); 6. The baseline blood routine and biochemical parameters of the subjects met the following criteria (no blood transfusion or blood products, no G-CSF or other hematopoietic stimulating factors were used within 14 days before the first medication) : Hemoglobin =90g/L; Absolute neutrophil count (ANC) =1.5×109/L; Platelets =80×109/L; ALT and AST = 2.5 times the upper limit of normal; ALT and AST = 5 times the upper limit of normal if patients with liver metastases; Serum total bilirubin =1.5 times the upper limit of normal; Serum Cr=1.5 times the upper limit of normal value or endogenous creatinine clearance >50ml/min (male: endogenous creatinine clearance =((140- age) × body weight)/(72× serum Cr); Female: Endogenous creatinine clearance =((140- age) × weight)/ (72× serum Cr) × 0.85; Weight unit: kg; Serum Cr unit: mg/mL); Serum albumin =30g/L; 7. No serious concomitant diseases that make the survival time less than 5 years; 8. Patients had good compliance and could comply with the protocol during the study; 9. Female subjects who are capable of pregnancy are required to have a negative serum pregnancy test within 72 hours before the first dose and to agree to use highly effective methods of contraception during the study treatment and for 90 days after the end of treatment; Male subjects with a fertile female partner should agree to use highly effective methods of contraception during treatment and for 90 days after the end of treatment; 10. Consent to provide blood and/or histological specimens.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients whose adverse events (other than hair loss) caused by previous treatment did not recover to grade =1 (CTCAE V5.0); 3. Patients with a history of other malignant diseases within the last 5 years or at the same time, except cured basal cell carcinoma of the skin and cervical carcinoma in situ; 4. If there is a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity of the disease will be judged by the researcher whether it prevents the signing of informed consent or affects the patient's oral medication compliance; 5. Clinically serious (i.e. active) heart disease that is not well controlled, such as: (1) symptomatic coronary heart disease, (2) New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring medical intervention, (3) previous myocardial infarction within the last 12 months, (4) QTc interval =450ms for men and =470ms for women, (5) LVEF2.0 or prothrombin time >16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy (allowing prophylactic use of low-dose aspirin, low molecular weight heparin, etc.); 11. Those who need immunosuppressive therapy for organ transplantation; Patients who have been treated with immunosuppressive agents or systemic corticosteroids to achieve immunosuppression within 14 days prior to treatment (e.g., prednisone > 10mg/ day or equivalent); 12. With active ulcer, unhealed wound or fracture; 13. Patients with hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 14. Previously received PD1/PD-L1 mab immunotherapy; 15. Urine routine indicated urinary protein = ++ and confirmed 24-hour urinary protein > 1.0g; 16. Serous effusion (including ascites, pleural effusion and pericardial effusion) with clinical symptoms requiring symptomatic treatment; Asymptomatic patients with serosal effusion were allowed to be enrolled. Patients with symptomatic serosal effusion that had been well controlled by active treatment such as drainage were allowed to be enrolled in the study. 17. Active hepatitis (hepatitis B reference: HBsAg positive with HBV DNA=500 IU/ml; HCV reference: HCV antibody positive and HCV virus copy number > the upper limit of normal); Patients in the active stage of infection who require antimicrobial therapy (e.g., ant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Disease control rate;adverse events;Lymphocyte subpopulations and cytokine levels; | — |
Countries
China
Contacts
Public ContactLiu aina
Yantai Yuhuangding Hospital
Outcome results
None listed