gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Radical gastrectomy with R0 resection has been performed; 3. ECoG PS score 0-1; 4. The expected survival time is more than or equal to 6 months; 5. The function of main organs was normal, and there was no severe abnormal blood, heart, lung, liver, kidney, bone marrow and immune deficiency. The laboratory examination meets the following requirements: (1) Hemoglobin (HB) >=90 g / L; (2) WBC >=3.0x10^9/L Neutrophil count (neut) >=1.5x10^9/L (3) Platelet count (PLT) >=100x10^9/L (4) Liver function (AST or ALT) level <=2.5 ULN; Renal function (SCR) level <=1.5 ULN; (5) Total bilirubin (TBIL) <=1.5 ULN; (6) Urinary protein and occult blood were less than 2 +; Fecal occult blood < 2 +. 6. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up; 7. Researchers believe that treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. Those who have been proved to be allergic to the test drug and / or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Have any active autoimmune disease or history of autoimmune disease; 4. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; Or history of organ transplantation; 5. There are not well controlled clinical symptoms or diseases of heart, such as: (1) heart failure of NYHA grade 2 or above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year. 6. Pregnant or lactating women; 7. According to the judgment of the researcher, the patients are not suitable for inclusion in this study; 8. Postoperative pathology showed positive margin; 9. Patients with lymph node metastasis; 10. Patients with systemic diseases and psychiatric diseases not suitable for chemotherapy; 11. Patients with acute infection need antibiotic treatment; 12. Patients who participated in clinical trials of other drugs within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Anhui Medical University