locally advanced gastric adenocarcinoma
Conditions
Interventions
A:give SOX for 5 cycles before operation
B:give SOX for 3 cycles before operation
Sponsors
the first Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Non-bedridden patients, aged 18 to 70 years old); (2) ECOG physical condition score was 0-1; (3) Gastric adenocarcinoma was confirmed by histopathology before operation; (4) Enhanced CT/MRI and ultrasonographic gastroscopy (diagnostic laparoscopic exploration if necessary) were performed before operation for clinical staging of cT4a-4bN0-3M0 (8th AJCC TNM); (5) The research center and the surgeon can complete the standard D2 radical operation, and preoperatively judge that the subjects may complete the radical operation; (6) Subjects met the following laboratory test criteria: (1) Hemoglobin (= 90g/L); Neutrophil absolute count (= 3*10^9/L); Platelet (= 100*109/L); Glutamic alanine aminotransferase and glutamic oxalate aminotransferase (= 2.5 ULN); Total bilirubin (= 1.5 ULN); Serum creatinine (= 1 ULN); Serum albumin (= 30 g/L); (7) Echocardiogram showed that the left ventricular ejection fraction was more than 50%. At the same time, the electrocardiogram was normal 4 weeks before operation, and there was no obvious clinical symptoms of heart disease; (8) There was no serious underlying disease that could lead to a life expectancy of less than 5 years; (9) Sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Positive pregnancy test for women of childbearing age, menopausal women with menopause for at least 12 months, can be regarded as no possibility of pregnancy; (3) Subjects who did not accept contraceptive requirements during the study period; (4) Those who had received chemotherapy, radiotherapy or immunotherapy at the front of this study; (5) In the past five years, patients had other malignant tumors except cervical carcinoma in situ; (6) In the past, there were uncontrolled diseases of the central nervous system, which the researchers determined would affect the overall compliance of the experiment; (7) Severe liver diseases (such as cirrhosis of the liver, nephropathy, respiratory diseases or uncontrollable diabetes, hypertension and other chronic system diseases; cardiac diseases with obvious clinical symptoms, such as congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia, hypertension difficult to control by drugs, or myocardial infarction attacks within 6 months, or cardiac insufficiency; (8) with dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation; (9) Organ transplantation requiring long-term immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR%; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;3-year DFS;5-year OS;side effects; | — |
Countries
China
Contacts
Public ContactChen Lin
the first Medical Center of Chinese PLA General Hospital
Outcome results
None listed