Gastric Cancer
Conditions
Interventions
Experimental Group:Combined Neoadjuvant Chemotherapy (NAC) and Laparoscopic Intraperitoneal Hyperthermic Chemotherapy (L-HIPEC) Followed By R0 Gastrectomy
Control Group:R0 Gastrectomy
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years to 70 years; 2. World Health Organization (WHO)performance status 0 to 2; 3. American Society of Anesthesiologists classification I to III; 4. Biopsy proven adenocarcinoma of the stomach; 5. MDCTendoscopic ultrasound or laparoscopy proven serosal invasion (T4); 6. with P0/CY1 or P0/CY0; Adequate bone marrow, hepatic and renal function. Acceptable laboratory values at recruitment: Absolute neutrophil count greater than or equal to 1.5 x 10^2/L; Platelet count greater than or equal to 100 x 10^9/L; Serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alanine transaminase and aspartate transaminase less than or equal to 2.5 ULN; Creatinine clearance greater than or equal to 50 ml/min (measured or calculated by Cockcroft-Gault formula); Negative pregnancy test (urine/serum) for female patients with childbearing potential; Life expectancy 3 months or greater; Able and willing to undergo blood sampling for pharmacokinetics; Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Distant metastases (eg. Liver, lung metastasispara-aortic lymph node) and other distant metastasis; 2. Macroscopic peritoneal metastasis, ovarian metastasis or malignant ascites; 3. Recurrent gastric cancer; 4. Prior resection of the primary gastric cancer; 5. Pregnancy, breast feeding, active pregnancy ambition, or unreliable contraceptive methods; 6. Uncontrolled infectious disease or known infection with human immunodeficiency virus; 7. known history of hepatitis B or C with active viral replication; 8. Recent myocardial infarction (less than 6 months) or unstable angina; 9. Uncontrolled diabetes mellitus; 10. Any medical condition that is considered to possibly, probably, or definitely interfere with study procedures (including adequate follow-up and compliance) and/or would jeopardize safe treatment; 11. Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Morbidity Rate; | — |
Countries
China
Contacts
Public ContactZhu Zhenggang
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed