gastric carcinoma
Conditions
Interventions
Test Group :Berberine combined with XELOX
control group :XELOX
Sponsors
Tianjin Fourth Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old, no gender limitation; 2. Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer; 3. Expected survival > 3 months; 4. ECOG PS score 0-2; 5. Has not received any anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. At least one measurable lesion outside the stomach (RECIST 1.1); 7. The functions of major organs within 7 days before treatment meets the following criteria: (1) Blood routine examination standards (no blood transfusion within 14 days) : A. WBC >4.0×10^9/L; B. Absolute value of neutrophils (ANC) =1.5×10^9/L; C. Hemoglobin (HB) =90g/L; D. Platelet (PLT) =90×109/L; (2) Biochemical tests shall meet the following standards: A. Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); B. alanine aminotransferase (ALT) and aspartate aminotransferase AST= 2.5ULN, if accompanied by liver metastasis, ALT and AST=5ULN; C. Serum creatinine (Cr) =1.5ULN or creatinine clearance (CCr)=60ml/min. D. Assessment of cardiac function by Doppler ultrasound: Left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%), no myocardial infarction within half a year, hypertension, and other coronary heart diseases within the range of control. 8. Did not participate in other research projects before or during treatment, or had finished or quit; 9. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with operable gastric cancer; 2. Patients with positive HER-2 and willing to receive herceptin treatment; 3. Those who have received other drug therapy (including Chinese medicine) before enrollment or cannot be guaranteed to follow the study requirements after enrollment; 4. Patients with a clear tendency to gastrointestinal bleeding; 5. Alcoholism or drug addiction; 6. Multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, complete intestinal obstruction, etc.); 7. Drug allergy to this program; 8. Pregnant or lactating women; 9. Female patients of childbearing age and those who wanted to have children during the study period; 10. According to the judgment of the researcher, patients with concomitant diseases seriously endanger patients' safety or affect patients' ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate(ORR);disease control rate(DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life(QOL);chemotherapy-related toxicity; | — |
Countries
China
Contacts
Public ContactXiaodong Han
Tianjin Fourth Central Hospital
Outcome results
None listed