gastric cancer
Conditions
Interventions
control group:chemotherapy after surgery
Experimental group 1:radiotherapy combined with immunotherapy before surgery
Experimental group 2:radiotherapy ? chemotherapy combined with immunotherapy before surgery
Sponsors
Changzhou 2nd People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with locally advanced or metastatic gastric or gastroesophageal carcinoma that is resectable and pathologically confirmed as adenocarcinoma; 3. patients must have at least one measurable or unmeasurable but evaluable lesion; 4. ECoG 0-1; 5. Patients with expected survival >=3 months; 6. Patients must have never received systemic treatment as the primary treatment for advanced or metastatic gastric cancer; 7. Patients should provide fresh or archived tumor tissue samples; 8. Patients with less severe hematopoiesis, heart, lung, liver and kidney dysfunction and immune deficiency; 9. Neutrophils >=1.5x10^9/L; hemoglobin >= 9g/dl; platelets >=100 x 10^9/L; total bilirubin <=1.5 ULN; ast (SGOT) and ALT (SGPT) <= 2.5 ULN; creatinine <=1.5 ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or a history of autoimmune disease (such as interstitial Pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy is effective), and have a history of using immunosuppressant within 28 days, but for the treatment of radiotherapy and chemotherapy Except for toxic hormones; 2. Patients with more than level 2 adverse events not recovered (i.e. level 1 or baseline level) caused by the treatment received before the first use of the study drug. According to the judgment of researchers, adverse events (such as neurotoxicity) that are difficult to recover quickly can be included in the group; 3. Those patients who were judged by the researchers to have non infectious pneumonia caused by previous radiotherapy and chemotherapy; 4. Patients who have received or are receiving other PD-1 antibody treatment or other immunotherapy for PD-1 / PD-L1; 5. Patients who are known to be allergic to macromolecular protein preparations, or to any of the components of Tislelizumab(shr-1210) and its preparations; 6. Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Patients with congenital or acquired immune deficiency (such as HIV infected patients), active hepatitis B (HBV-DNA >=104 copies / ml) or hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or active tuberculosis; 8. Patients with active infection or fever with unknown cause more than 38.5 degrees C within 2 weeks before randomization (according to the judgment of the researcher, the fever of the subject due to tumor can be included in group); 9. The fertile male or female is unwilling to take contraceptive measures in the test, and the female patient is pregnant or lactating; 10. According to the researcher's judgment, there are other factors that may cause him / her to be forced to terminate the study midway, such as other serious diseases (including mental diseases) requiring combined treatment, family or social factors, which may affect the safety of the subject or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS;ct-DNA;T cell subsets;tumor immune microenvironment;PD-1/PD-L1;cytokines; | — |
Contacts
Public ContactJiang Hua
Changzhou 2nd People's Hospital
Outcome results
None listed