The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.
Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Product 1: endostar Dosing schedule: 15mg daily dose, d1-14 Mode of administration: intravenously
Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally
Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously
Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing Municipality, China
Progression free survival
Time frame: 3 year
Tumor response rate
Time frame: 1 year
Disease control rate
Time frame: 1 year
Overall survival
Time frame: 5 year
adverse evens
Time frame: 5 year
The alteration of relative regional blood volume of the tumor
Time frame: 3weeks
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