Untreated local gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
A:SHR-1210, Oxaliplatin, Tiggio
B :Oxaliplatin, Tiggio
Sponsors
China-Japan Friendship Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 72 Years
Inclusion criteria
Inclusion criteria: 1) 18-72 years old (unlimited for men and women); 2) Untreated local gastric/gastroesophageal junction adenocarcinoma (clinical tumor stage T2N+, or T34aN+/, no distant metastasis (M0); 3) According to the evaluation criteria, surgery is planned after preoperative chemotherapy; 4) Within 3 days before the first dose of the study treatment drug, according to the ECOG score of 0 to 1; 5) According to the solid tumor response assessment standard (RECIST1.1), at least one diameter of the lesion can be accurately measured; 6) Male participants with fertility must agree to use appropriate contraceptive methods during the study within 180 days after the last dose of chemotherapy; 7) Female fertile participants must be willing to use appropriate contraceptive methods during the study, until 180 days after the last chemotherapy or 120 days after the last dose of carrelizumab. 8) Laboratory indicators are as follows: Platelet count >= 60 x 10^9/L, hemoglobin >= 8.5g/dl, albumin >= 3.0g/dl, total bilirubin 50 ml/min, prothrombin time international normalized ratio (PT-INR) <=2.3 or prothrombin time (PT) exceeds 6 seconds of normal control within. 9) Patients included in this study must sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) The patient has distant metastasis or infiltration of adjacent organs; 2) The patient has had an autoimmune disease; 3) Known or suspected to be allergic to the tested drug or to any drug given in connection with this test; 4) The patient himself has received an organ transplant or is an HIV patient; he has received a live vaccine within 30 days before the first dose of the study drug; 5) Those who are allergic or intolerant to the research drug or placebo; 6) Congestive heart failure> New York Heart Association (NYHA) Class II; Active coronary artery disease (patients with myocardial infarction that occurred 6 months before enrollment can be enrolled); 7) Patients with arrhythmias need to receive anti-arrhythmic treatment (except ß-receptor-blockers, calcium antagonists or digoxin); 8) The patient has serious non-surgical diseases or active clinical serious infections (> Grade 2 NCI-CTCAE3.0 version); 9) Known central nervous system tumors, including brain metastases or uncontrollable mental diseases; 10) The patient had clinically obvious gastrointestinal bleeding within 30 days before enrollment or the patient himself had clinical indications of liver and kidney damage such as chronic renal failure; Any unstable conditions or situations that may endanger the safety of the patient and his/her compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete resection rate;ORR;DFS;Surgical complications;safety; | — |
Countries
China
Contacts
Public ContactFuJianJi
China-Japan Friendship Hospital of Jilin University
Outcome results
None listed