Gastric or gastroesophageal adenocarcinoma
Conditions
Interventions
Test Group:Adebrelimab+Oxaliplatin+S-1
Sponsors
Lianyungang First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in this study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. Age: 18-75 years old, gender not limited; 3. Patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction diagnosed by pathology; 4. The clinical stage evaluated by CT/MRI images was cT3-cT4 N0-2 M0; 5. There is a possibility of radical resection as evaluated by CT/MRI images; 6. Physical condition score: ECOG 0-1 (ECOG scoring criteria are attached as Appendix 1); 7. The expected survival period is >= 3 months; 8. Has not received any anti-tumor treatment for metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction in the past, including radiotherapy, chemotherapy, surgery, etc. 9. There are no serious abnormalities in hematopoietic function, heart, lung, liver or kidney function, or immune deficiency. 10. The main organ functions are normal, including (no blood components, cell growth factors, whitening drugs, platelet-increasing drugs, or anemia-correcting drugs are allowed to be used within 14 days before the first use of the study drug) : Neutrophils >= 1.5×10^9/L; Hemoglobin >= 9g/dL; Platelet count >= 100×10^9/L; Total bilirubin <= 1.5 times the upper limit of the normal value; AST (SGOT) and ALT (SGPT)<= 2.5 times the upper limit of normal values; Creatinine <= 1.5 times the upper limit of the normal value. 11. The subjects voluntarily joined this study, had good compliance, and cooperated with the follow-up of safety and survival.
Exclusion criteria
Exclusion criteria: 1. Previously or concurrently suffering from other malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Participated in clinical trials of other drugs within 4 weeks; 3. Have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after effective hormone replacement therapy), etc.) and use immunosuppressants within 28 days; 4. It is known that there is an allergy to large molecule protein preparations, or to any adbelimab monoclonal antibody (SHR-1316) and the components in its preparations; 5. Suffering from uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris (3) Had a myocardial infarction within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require clinical intervention; 6. Suffering from congenital or acquired immune dysfunction (such as HIV-infected individuals), active hepatitis B (HBV-DNA>= 10^4 copies/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method) or active tuberculosis; 7. There is an active infection with a fever of unknown cause > 38.5? within 2 weeks (as determined by the researcher, the fever caused by the tumor in the subjects can be included in the group); 8. Fertile men or women who were unwilling to take contraceptive measures in the trial, and female patients who were pregnant or lactating; 9. According to the researcher's judgment, the subject has other factors that may cause them to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, family or social factors that may affect the safety of the subject or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease free survival;Overall survival;Disease control rate;Quality of life score;Safety; | — |
Countries
China
Contacts
Public ContactZhengdong Wang
Lianyungang First People's Hospital
Outcome results
None listed