In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14; Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.
Jilin Provincial Tumor Hospital
Changchun, Jilin, China
RECRUITINGResponse rate
Evaluate the objective response rate followed by RECIST 1.1.
Time frame: 6-8 weeks
Adverse events
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit.
Time frame: 1 year
Overall survival
Time frame: 3 year
Progress free survival
Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response.
Time frame: up to 9 weeks
Disease control rate
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time frame: up to 9 weeks
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