Gastric cancer
Conditions
Interventions
NIPS:Intravenous and intraperitoneal paclitaxel plus oral S-1
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed gastric adenocarcinoma; 2. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy (with or without ovarian metastasis in female patients); 3. Patients without gastric outflow tract obstruction and intestinal obstruction; 4. No prior treatment with chemotherapy, radiation therapy, targeted therapy or immunotherapy; 5. Age between 18 and 75 years at registration; 6. Eastern Cooperative Oncology Group (ECOG) score = 3 months; 8. Adequate bone marrow, liver, and renal functions; 9. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Signs of distal metastasis other than the peritoneum; 2. Pregnant or lactating women; 3. History of other malignancies within 5 years; 4. The severity of patients with uncontrolled epilepsy, central nervous system disease or psychogeny should be judged by the researchers, which may hinder the compliance of signing informed consent or drugs intaking; 5. Patients with heart disease with apparent clinical symptoms, coronary heart disease with symptoms, grade II or more severe congestive heart failure, drug controllable arrhythmia, and myocardial infarction within 12 months; 6. Patients associated with upper gastrointestinal tract obstruction or dysfounction, or with malabsorption syndrome, which may affect S-1 absorptioin; 7. The existence of the peripheral nervous system disorders >= NCI-CTC AE I,but with only the disapperance of deep tendon reflex should not be excluded; 8. The history of organ transplants and the needs of immunosuppression therapy; 9. Uncontrolled severe inflammation or suffered other severe diseases; 10. Moderate or severe renal impairment (CCR <= 50 ml/min), or serum creatinine greater than normal line; 11. Patients lack of dihydropyrimidine dehydrogenase; 12. Allergy to PTX or other drugs in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| toxic effects;Conversion surgery outcomes;3-year median survival time; | — |
Countries
China
Contacts
Public ContactZhenggang Zhu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed