gastric cancer
Conditions
Interventions
1:Anti PD-1 immunotherapy
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Both men and women should be over 18 years old and less than 75 years old; 3. Stage IV gastric cancer with failed first-line chemotherapy and high expression of nets; 4. ECoG score: 0-1; 5. High expression of nets was detected in peripheral blood (mpo-dna >= 0.5); 6. Six Female patients of non-surgical sterilization or childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; the serum or urine HCG test of non-surgical sterilization women of childbearing age must be negative within 72 hours before the study enrollment; and they must be non lactating; for men, they should be in non lactation period Should be surgical sterilization, or agree to use appropriate methods of contraception during the trial period and within 3 months after the last administration of the trial drug. 7. The baseline blood routine and biochemical indexes of the selected patients should meet the following criteria: a. Hemoglobin >= 90g / L b. Absolute neutrophil count >= 1.5 x 10^9 / L c. Platelet count >= 100 x 10^9 / L d. Aspartate or alanine aminotransferase <= 2.5 times of the upper limit e. Alkaline phosphatase <= 2.5 times the upper limit of normal (ULN) f. Thyroid stimulating hormone (TSH) <= 1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age were positive in the baseline pregnancy test; 3. Distant metastasis was diagnosed by CT / MR / EUS; 4. Other malignant tumors (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) in the past 5 years; 5. Uncontrollable pleural effusion, pericardial effusion or ascites; 6. Severe cardiovascular diseases, such as symptomatic coronary heart disease, congestive heart failure = grade II, uncontrolled arrhythmia and myocardial infarction within 12 months before enrollment; 7. Complicated with upper gastrointestinal obstruction / bleeding or digestive dysfunction or malabsorption syndrome, which may affect the absorption of S-1; 8. Severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury; 9. Allergic reaction to the drugs used in this study; 10. Steroid therapy or other systemic immunosuppressive therapy was used 14 days before enrollment; 11. Patients who received study drug treatment within 4 weeks before enrollment (participating in other clinical trials). 12. Active autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism who only needed hormone replacement therapy, and skin diseases (such as vitiligo, psoriasis, or alopecia) that did not require systemic treatment were included. 13. History of primary immunodeficiency. 14. Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding nasal, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. prednisone not exceeding 10 mg / day or other equivalent doses of other glucocorticoids), or use of hormones to prevent allergy to contrast media. 15. Receive live attenuated vaccine within 4 weeks prior to the first dose of study treatment or during the study period. 16. Active tuberculosis is known. 17. The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation is known. 18. HIV antibody positive, active hepatitis B or hepatitis C (hepatitis B: HBsAg positive and HBV-DNA >= 10 copies / ml; hepatitis C: HCV antibody and HCV-RNA positive, need antiviral treatment at the same time). 19. Other factors that may affect the safety or compliance of the test determined by the researcher. For example, serious diseases (including mental diseases), serious laboratory abnormalities, or other family or social factors that need to be treated together. 20. Vulnerable groups without or with limited capacity for civil conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overeall survival; | — |
Countries
China
Contacts
Public ContactXia Xiang
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed