gastric cancer
Conditions
Interventions
nab-Paclitaxel fixed dose Ramcirmab fixed dose
Sponsors
Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed gastric cancer. 2. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer. 3. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration. 4. No influence of prior therapy. 5. PS 0-2 6. Age >=20 7. Expected more than 3 months survival 8. Adequate organ functions (within 14 days before registration) Leu: >=3,000 /mm3, <=12,000 /mm3 Neu: >= 1,500 /mm3 Plt: >= 100,000 /mm3 Hemoglobin: >= 9.0 g/dL ALT: <=ULNx2.5 AST: <=ULNx2.5 T-bil: =<1.5mg/dl Scr: >= 1.5 mg/dl 9. With written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with serious drug allergy 2. Patients with history of receiving paclitaxel treatment 3. Patients with infectious disease and febrile condition (over 38 centigrade) 4. Patiens with any other serious disease. 5. Patients with history of gastrointestinal perforation and fistula 6. Patients with venous thrombosis and fresh bleeding from intestinal tract. 7. Patients with serious heart disease 8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.) 9. Patients with peripheral neuropathy(=>Grade2) 10. Patients wit psychological illness 11. Pregnant or nursing female 12. Patient with brain metastasis. 13. Patient with mental illness 14. Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Response rate (RR) Disease control rate (DCR) Safety (Safety) Relative dose intensity (RDI) | — |
Countries
Japan
Contacts
Public ContactMichihisa Iida
Yamaguchi University Graduate School of Medicine Department of Gastroenterological, Breast and Endocrine Surgery
Outcome results
None listed