gastric cancer
Conditions
Interventions
test group:AI nutrition management system+sintilimab+chemotherapy
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent before enrollment; subjects voluntarily joined the study, with good compliance, and cooperated with safety and survival follow-up. 2.Age =18 years old, both male and female; 3.Pathologically confirmed adenocarcinoma of the stomach/gastroesophageal junction, and negative for HER-2 expression; 4.ECOG score: 0-1, healthy limbs; 5.Expected survival time greater than three 6.Have measurable lesions (according to the RECIST 1.1 standard, the long diameter of non-lymph node lesions on CT scan is =10 mm, and the short diameter of lymph node lesions on CT scan is =15 mm); 7.The function of vital organs meets the following requirements (excluding those used within 14 days) Any blood components and cell growth factors): 1) Blood routine: neutrophils = 1.5 × 109/L; platelet counts = 100 × 109/L; hemoglobin = 90 g/L; 2) Liver and kidney function: serum creatinine (SCr ) = 1.5 times the upper limit of normal (ULN) or creatinine clearance = 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or glutathione Alanine aminotransferase (ALT) level = 2.5 times the upper limit of normal (ULN) (= 5 ULN if abnormal liver function is due to liver metastases); urine protein < 2+; if urine protein = 2+, 24-hour urine protein quantification The protein must be less than or equal to 1g; 8.Normal coagulation function, no active bleeding and thrombotic diseases: 1) International normalized ratio INR = 1.5×ULN; 2) Partial thromboplastin time APTT = 1.5×ULN; 3) Prothrombin time PT=1.5×ULN; 9.Non-surgical sterilization or female patients of childbearing age, need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptives or within 3 months after the end of the study treatment period) condoms); non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; Use a medically approved contraceptive method during the study treatment period and for 3 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1.The subjects have suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 2.The subjects who have received other PD-1/PD-L1 inhibitor therapy in the past cannot be enrolled; Know that the subject has been allergic to macromolecular protein preparations, or known to be allergic to the applied drug components; 3.The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune Hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subjects with vitiligo or in childhood Those whose asthma has been completely relieved in the adult stage can be included without any intervention after the adult; those whose asthma requires bronchodilator medical intervention cannot be included); 4.The subjects are using immunosuppressants, or systemic, or absorbable topical Hormone therapy for the purpose of immunosuppression (dose>10mg/day prednisone or other hormones with equivalent efficacy), and continued use within 2 weeks before enrollment; 5.Used intravenous antibiotics, probiotics within the past 4 weeks Bacterial products and prebiotic products; 6.Ascites or pleural effusion with clinical symptoms, which requires therapeutic puncture or drainage; 7.There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure (2) Unstable angina pectoris (3) Myocardial infarction within 1 year (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 8.Subjects still using it within 2 weeks before enrollment Traditional Chinese medicine immunomodulators; 9.Subjects with active infection or unexplained fever >38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subjects with fever due to tumor can be enrolled); 10.Previous and patients with objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.; 11.Subjects with congenital or acquired immunodeficiency, such as HIV-infected patients , or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA = 1000 IU/ml; hepatitis C reference: HCV RNA = 1000 IU/ml); chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml , and must receive antiviral treatment during the trial period to be enrolled; 12.Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period; 13.The subject has a known history of psychotropic substance abuse, alcoholism or drug addiction; 14.Subjects received traditional Chinese medicine treatment within 4 weeks before the first treatment; 15.The researcher believes that they should be excluded from this study, for example, the researcher judges that the subjects have other factors that may lead to the forced termination of this research halfway , For example, other serious diseases (including mental diseases) require combined treatment, there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PG-SGA score;overall survival;QOL score;?PA;Metagenetic and metabolomic differences; | — |
Countries
China
Contacts
Public ContactXiaoling Zhang
Changzhi People's Hospital
Outcome results
None listed