Advanced gastric cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.With pathologically proven gastric cancer 2. S-1 failure for Patients with Advanced and Recurrent Gastric Cancer 3. ECOG performance status<=2 4. Age 20 years old or more 5. Life expectancy estimated>=12 weeks 6. Sufficient organ functions
Exclusion criteria
Exclusion criteria: (1) Blood transfusion, blood products, or hematopoietic factor products, such as G-CSF, within 14 days before enrollment of this study. (2) Present and/or drug hypersensitivity or severe drug allergy. (3) Active double cancer. (4) With uncontrolled pleural effusion or ascites. (5) With pericardial effusion. (6) With infectious disease which needs treatment. (7) With symptomatic brain metastasis. (8) With marked ECG abnormalities. (9) With serve heart diseases, such as congestive heart failure, symptomatic coronary artery disease, inadequately controlled arrhythmia, myocardial infarction during the previous 12 months, etc. (10) With severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.). (11) With fresh gastrointestinal hemorrhage. (12) Watery stool (diarrhea). (13) Intestinal paralysis or ileus. (14) With a history of central nervous system disorder. (15) With senile dementia. (16) With psycologic disorder which disturbs recruiting to the study (17)Uncontrolled diabetes mellitus. (18) Receiving atazanavir sulfate. (19) Pregnant and/or nursing women. (20) Inappropriate recruit to the study judged by an investigator in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival: OS | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS: Progression-free survival TTF: time to treatment failure RR: Response rate DCR: Disease control rate Adverse events | — |
Countries
Japan
Contacts
Osaka National Hospital Department of Surgery