gastric cancer
Conditions
Interventions
Exposure group (Yiwei granules + Chemotherapy + Immunotherapy):Yiwei granules
Non-exposure group (chemotherapy+ Immunotherapy):chemotherapy+ Immunotherapy
Sponsors
Tongde Hospital of Zhejiang province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Patients who meet the diagnostic criteria and are confirmed to be stage IIIB to IV gastric cancer through imaging examinations such as CT MRI B-ultrasound and cytology or pathology examinations; 2)Patients with negative HER2 expression unrestricted PD-1 and PD-L1 expression confirmed by immunohistochemistry (IHC) or in situ fluorescence hybridization (FISH) and expected first-line chemotherapy with immune checkpoint inhibitors with a survival expected to be greater than 3 months; 3)Patients with spleen deficiency and phlegm-dampness syndrome in TCM syndrome differentiation; 4)Patients were gender-independent aged 18-75 years; KPS score =60 points; 5)patients who can adhere to medication as prescribed by the doctor (taking Yiwei granules for =3 months) have good compliance understand the situation of this study and sign informed consent form; 6)No major organ dysfunction normal blood routine liver kidney and heart function: hemoglobin =100g/L absolute neutrophil count (ANC) =1.5×109/L platelets =100×109/L bilirubin =l.5ULN alkaline phosphatase (APL) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times the upper limit of normal (ALT =5ULN is allowed if there is liver metastasis).International normalized ratio (INR) =1.5 ULN.Activated partial thromboplastin time (APTT) =1.2 ULN creatinine =1.5 ULN.
Exclusion criteria
Exclusion criteria: 1)patients with two or more primary malignancies who have been treated with second-line or above protocols; 2)Patients with an expected survival of <3 months; 3)Patients with any acute or chronic diseases or abnormalities in laboratory tests that may increase the risk of participating in the study or study medication or have an impact on the research results and the patient is deemed unsuitable for inclusion in the study by the investigator.These conditions include: a.Uncontrolled hypertension unstable angina myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia in the last 12 months.those with significant ischemic changes on ECG; b.Active stage of disease in bacterial fungal or viral infections; c.Having dementia or major alterations in mental status renders it unable to understand or express informed consent. 4)Patients who are pregnant or breastfeeding; 5)Patients who were allergic to a drug or were participating in a trial of another drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year patient survival ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;physical status score;overall survival;TCM symptom score; | — |
Countries
China
Contacts
Public ContactTraditional Chinese Medicine Oncology
Tongde Hospital of Zhejiang province
Outcome results
None listed