It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProgression-free Survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death.
Time frame: up to 3 years
Overall Response Rate (ORR)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
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 4.03
Time frame: up to 3 years
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