Borrmann large type 3 or type 4 gastric cancer
Conditions
Interventions
Experimental group:Preoperative POS chemotherapy
Experimental group:D2 gastrectomy
Experimental group:Postoperative treatment with oral S-1, intravenous and intraperitoneal paclitaxel
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Histologically confirmed GC 2: Resectable Borrmann type 3 (=8cm) or type 4 GC (evaluated by CT) 3: No signs of distant metastases (M0) 4: Esophageal infiltration =3cm 5: Age between 18 and 75 years at registration 6: Eastern Cooperative Oncology Group score of 0-1 7: No prior treatment of chemotherapy, radiation therapy, targeted therapy or immunotherapy 8: Non-gastric stump cancer or recurrent gastric cancer 9: No peritoneal metastasis (P0/CY0) by laparoscopic 10: No need for combined thoracoabdominal incision, Appleby procedure, or combined pancreaticoduodenectomy (combined colon resection, pancreatic resection, splenectomy, and hepatectomy are allowed) 11: No gastrointestinal obstruction 12: Adequate organ function, including: hematology (WBC=3.0×109/L, NE=1.5×109/L, Hb=80 g/L, PLT=100×109/L), liver function (bilirubin=1.5 times the upper limit of normal, AST and ALT=2.5 times the upper limit of normal and renal function (creatinine clearance rate= 50 mL/min) 13: Fertile women must have a negative pregnancy test in urine or serum within 7 days before enrollment and commit to contraception throughout the study and for one month after the end of the study 14: Must sign an informed consent form, have good compliance, and be able to cooperate with relevant examinations, treatments, and follow-ups
Exclusion criteria
Exclusion criteria: 1: R1 or R2 resection, or baseline assessment after surgery suggests the presence of distant metastases 2: Her2-positive 3: Pregnant or lactating women 4: Other primary malignant tumors other than gastric cancer within 5 years 5: Emergency surgery 6: Active bleeding signs during endoscopy 7: Gastrointestinal perforation within 6 months 8: Severe uncontrolled infectious diseases, HIV-infected individuals, uncontrolled active HBV, active HCV-infected individuals 9: Body temperature =38.0? 10: Poorly controlled underlying diseases, including but not limited to: severe mental illness, severe (active) valvular heart disease, dilated or hypertrophic cardiomyopathy, myocardial infarction or unstable angina within 6 months, interstitial pneumonia, pulmonary fibrosis, or severe emphysema, uncontrolled diabetes or hypertension 11: Allergy to the components of the drugs used 12: Currently participating in other interventional clinical research treatments 13: Other factors that the investigator deems unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year peritoneal recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival;3-year overall survival;adverse events; | — |
Countries
China
Contacts
Public ContactChao Yan
Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital
Outcome results
None listed