Gastric cancer
Conditions
Interventions
Case series:NA
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. Patients voluntarily join the study and sign an informed consent form 2. = 18 years old, = 75 years old, both men and women 3. There is histologically confirmed, untreated gastric cancer or gastroesophageal junction (GEJ) cancer, and histological examination confirms that pT4NxM0 gastric cancer is mainly adenocarcinoma. 4. ECOG score: 0~1 5. Have not received anti-tumor therapy for gastric cancer before surgery, including chemotherapy, targeted, immune and local radiotherapy
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age are positive at baseline pregnancy test; 3. Diagnosis of distant metastasis by CT/MR/EUS; 4. Received prior antitumor therapy, including chemotherapy, radiotherapy, targeted or immunotherapy; 5. Other malignancies (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) in the past 5 years; 6. Uncontrollable pleural effusion, pericardial effusion or ascites; 7. Severe cardiovascular disease, such as symptomatic coronary heart disease, congestive heart failure of grade = II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment; 8. Complicated by upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome; 9. Complicated by severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; 10. Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment; 11. Patients receiving study medications within 4 weeks prior to enrollment (participation in other clinical trials). 12. Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment, etc.). Participants with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy (e.g. vitiligo, psoriasis or hair loss) were eligible. 13. History of primary immunodeficiency. 14. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or equivalent dose of other glucocorticoids), or use of hormones to prevent contrast allergy. 15. Receive live attenuated vaccine within 4 weeks prior to the first dose of study treatment or planned for the duration of the study. 16. Patients with known interstitial pulmonary pneumonia and active pulmonary tuberculosis. 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 18. HIV-positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA=104copies/ml; Hepatitis C: positive for HCV antibodies and HCV-RNA, requiring concurrent antiviral therapy); 19. Other factors that may affect participant safety or trial adherence as judged by the investigator. Such as serious illness (including mental illness), serious laboratory abnormalities, or other family or social factors that require treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of peritoneal metastasis 1 years after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of peritoneal metastasis 2 years after surgery;Disease progression rate 2 years after surgery;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Zizhen
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed