gastric
Conditions
Interventions
Group A:Intraperitoneal and intravenous nab-paclitaxel combine with S-1
Sponsors
The Second Affiliated Hospital, Zhejiang University College of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Tissue or cytology confirmed as gastric adenocarcinoma, no history of surgical resection of primary or metastatic lesions; 2. Gastric cancer peritoneal metastasis needs to be diagnosed by laparoscopy, but not accompanied by gastric outflow obstruction and intestine obstruction; 3. In the newly diagnosed patient, no chemotherapy or radiotherapy was performed before the start of the clinical trial; 4. Aged 18-75 years; 5. ECOG score 3 months; 7. Laboratory tests can tolerate surgery and chemotherapy; 8. Hematology: no obvious signs of hematological disease, before the enrollment ANC >= 1.5 x 10^9 / L, platelet count >= 100x10^9 / L, Hb >= 90 g / L, WBC >= 3.0x10^9 / L, and no bleeding tendency; 9. Biochemical examination: total bilirubin < 1.5 times the upper limit of normal, AST, ALT < 2.5 times the upper limit of normal, creatinine < 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. There are signs of distant metastasis other than peritoneal metastases; 2. Pregnant or lactating women; 3. Those with a history of other malignant tumors in the past 5 years; 4. Those with uncontrolled epilepsy, central nervous system disease or mental disorder, judged by the investigator Whether its clinical severity hinders the signing of informed consent or affects the patient's oral medication compliance; 5. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York heart disease Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring medication intervention Often, or have a history of myocardial infarction within the last 12 months; 6. Upper gastrointestinal obstruction or abnormal physiological function, or suffering from malabsorption syndrome, may affect S-1 absorber; 7. Known to have peripheral neuropathy >= NCI-CTCAE Level 1. But only deep sputum reflex (DTR)the disease that disappears can not be ruled out; 8. Organ transplantation requires immunosuppressive therapy; 9. Uncontrolled severely infected persons, or other serious concomitant diseases; 10. Known to suffer from dihydropyrimidine dehydrogenase (DPD) deficiency; 11. Those who are allergic to paclitaxel or any research ingredient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| three-year overall survival rate rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| conversion surgery rate;safety;efficacy; | — |
Countries
China
Contacts
Public ContactWu Dan
The Second Affiliated Hospital, Zhejiang University College of Medicine
Outcome results
None listed