Gastirc Cancer
Conditions
Interventions
Observation group:NA
Sponsors
the first affiliated hospital of Sun Yat-set University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination 2. HER-2 negative 3. PD-L1 expression detection CPS 2 weeks 8. At least one measurable lesion or evaluable lesion according to RECIST v1.1 9. Have adequate organ and bone marrow function 10. Expected survival time =12 weeks 11. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age must take effective contraceptive measures during the entire treatment period and within 6 months after the treatment period. 12. Sign written informed consent and be able to comply with the visits and related procedures stipulated in the plan
Exclusion criteria
Exclusion criteria: 1. Active bleeding from the lesion 2. Cardia and pylorus obstruction 3. HER2 positive 4. Previous systemic treatment for advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction 5. Diagnosed with other malignant diseases other than gastric cancer within 5 years before the first dose 6. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks before the first dose. 7. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors 8. Have received Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within 2 weeks before the first dose 9. Active autoimmune disease requiring systemic treatment occurred within 2 years before the first dose 10. Are receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 7 days before the first dose of the study 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 12. Known to be allergic to ingredients of any monoclonal antibody or chemotherapy drug (capecitabine, Tigeol, oxaliplatin) (experienced grade 3 or above allergic reaction) 13. Have not fully recovered from toxicity and/or complications resulting from any intervention before initiating treatment 14. Known history of human immunodeficiency virus (HIV) infection 15. Untreated active hepatitis B 16. Subjects with active HCV infection 17. Administer live vaccine within 30 days before first dose (cycle 1, day 1) 18. Pregnant or lactating women 19. Any serious or uncontrollable systemic disease 20. Evidence of medical history or disease, abnormal treatment or laboratory test values that may interfere with the trial results, prevent the subject from fully participating in the study, or other circumstances that the researcher believes are not suitable for enrollment. The researcher believes that there are other potential risks and are not suitable for participation. this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;safety; | — |
Countries
China
Contacts
Public ContactJianjun Peng
the first affiliated hospital of Sun Yat-set University
Outcome results
None listed