This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting
This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
616
nab paclitaxel (120mg/m2;iv;d1,8)
S-1 (\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)
Oxaliplatin(130mg/m2 , iv, d1)
Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences
Hangzhou, Zhejiang, China
RECRUITING3 years Diseases-free Survival rate(3 years-DFS)
DFS is defined as time from the date of inclusion up to the date of disease progression or death
Time frame: up to 3 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Time frame: up to 3 years
Safety as measured by number and grade of adverse events
Summary adverse events according to NCI-CTCAE 5.0
Time frame: up to 3 years
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Capetabine(1000 mg/m2 po, d1-14 bid )