Gastric Carcinoma
Conditions
Interventions
Sponsors
Shanghai Changhai Hospotal
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. The age is 18 years old and above; 3. Expected survival >= 12 weeks; 4. The microsatellite status is MSI-H; 5. Perform D2 radical resection and achieve R0 resection, postoperative histopathological confirmation is gastric or gastroesophageal junction adenocarcinoma, and the pathological stage is stage III; 6. Have not received systemic therapy such as chemotherapy; 7. Archived surgical tumor tissue samples are required; 8. ECOG score is 0-1; 9. Within 28 days prior to the first dose, laboratory^ tests have adequate organ function: (1) Blood routine: WBC >= 3.0x10^9/L; ANC >= 1.5x10^9/L; PLT >= 100x10^9/L; HGB >= 90 g/L; (2) Liver function: AST = 60 mL/min; (4) Coagulation function: INR <= 1.5, APTT <= 1.5xULN; (5) There was no obvious abnormality in the electrocardiogram. 10. Male subjects and females of childbearing age must take contraceptive measures within 3 months from the start of the first dose to the last use of the study drug.
Exclusion criteria
Exclusion criteria: 1. History and complications (1) The subject has any known active autoimmune disease (subject such as stable clinical symptoms and no need for systemic immunosuppressants, such as type I diabetes mellitus and hypothyroidism requiring only hormone therapy, no systemic Treated skin diseases can be enrolled); (2) The subject has any complications that require systemic treatment with glucocorticoids such as prednisone (>10 mg/day) or has used immunosuppressive drugs within 14 days before the first dose (if there is no active autoimmune disease, inhaled Or topical corticosteroids, and prednisone (>10mg/day) for hormone replacement therapy for adrenal insufficiency subjects can be enrolled); (3) The subject has received tumor vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first administration; (4) The subject is participating in other clinical trials or has received drug intervention in other clinical trials within 4 weeks before the first dose; (5) The subject has undergone surgery or received >30Gy of radiation therapy within 4 weeks before the first administration; (6) The subject has other malignant tumors that need to be treated (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast or carcinoma in situ of the cervix has received radical treatment and no other treatment is required. Subjects can be enrolled) ; (7) The subject has suffered from severe cardiovascular disease in the past: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 480 ms); cardiac insufficiency grade III to IV; cardiac color Doppler ultrasound The examination showed that left ventricular ejection fraction (LVEF) was less than 50%; (8) The subject has a known history of allogeneic organ transplantation and allogeneic hematopoietic hepatocyte transplantation; (9) The subject has received a live vaccine within 30 days before the first dose. 2. Laboratory tests (1) The subject's serum was HIV positive; (2) Active hepatitis B (HbsAg positive and HBV-DNA >=103copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, and antiviral treatment is required). 3. Allergies and adverse drug reactions should be excluded (1) Hypersensitivity or hypersensitivity reactions to monoclonal antibodies; (2) Allergy or intolerance occurs during the infusion. 4. Subjects suffering from mental illness, alcoholism, drug addiction, etc. should be excluded; 5. Diseases or abnormal laboratory indicators that the investigator believes will affect the results of the study, or are not in the interests of the subjects, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;safety; | — |
Countries
China
Contacts
Public ContactNie Mingming
Changhai Hospital of Shanghai
Outcome results
None listed