This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.
The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, , The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Irinotecan(Camptosar)150mg /m2 d1,(intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer
Department of Oncology,The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
PFS and OS
Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: 1. Complete response (CR) 2. Partial response (PR) 3. Stable disease(SD) and progression disease(PD) 4. CR + PR is efficient.
Time frame: 2 years
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