gastric carcinoma
Conditions
Interventions
experimental group:Magnesium sulfate 0.1g /kg for 12 hours qd (D1-2), every 21 days for a cycle (3 cycles)
Control group:None
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1, age 18-75 years old; 2. The patient's Karnofsky score was greater than or equal to 70, and the Zubrod-ECOG-WHO score was greater than or equal to 2 (see Attachment 3 respectively); 3. Gastric adenocarcinoma was confirmed by histopathology, with TNM stages of ?A, ?B, ?A, ?B and ?C ( the staging was referred to the 8th edition of AJCC UICC gastric cancer staging in 2018); 4. Had not received anti-tumor therapy before enrollment; 5, no other important related diseases (such as other tumors, serious heart and central nervous system diseases, etc.); 6. Baseline blood routine and biochemical indexes meet the following standards: Neutrophil count =1.5×109/L; Hemoglobin =80 g/L; Platelet count =100×109/L; Total bilirubin =1.5×ULN; ALT, AST=2.5 x ULN; Serum Cr=1.5×ULN, endogenous creatinine clearance =60ml/min (Cockcroft-Gault formula) 7. Expected survival =6 months; 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to admission, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug. For men, they should be surgically sterilized or consent to an appropriate method of contraception during the trial and for 8 weeks after the last dose of the trial drug. 9. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with other malignant tumors within 5 years; 3, with a history of psychiatric drug abuse and can not quit or have mental disorders; 4. Patients who have participated in clinical trials of other drugs within 4 weeks; 5. Had received other antitumor drugs before enrollment. 6. Patients with concomitant diseases that, according to the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 7. Those who are not considered suitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Tissue regression Scale (TRG scale); | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor shrinkage (RECIST rating);R0 removal rate;Number of lymphocyte subsets;Magnesium ion in tumor tissue;Lymphocyte differentiation subtype; Tumor-infiltrating natural killer (NK) cells;Laboratory indicators (blood routine, liver and kidney function, electrolytes); | — |
Countries
China
Contacts
Public ContactXie Jiebin
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed