The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.
As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a first-line treatment for patients with metastatic gastric cancer. All patients were orally treated with S-1 in doses of 40 mg (BSA\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
40mg QD D1-D14,every 3 weeks,for BSA\<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA\>1.5m2,until disease progress or intolerable toxicity.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progression-free survival
Progression-free survival is determined from the date of treatment to PD or death.
Time frame: through study completion, an average of 2 years
Response rate
the ratio of patients whose efficiency evaluation is CR or PR
Time frame: up to one year
Overall survival
the date of treatment to death from any cause or the last follow-up date
Time frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first.
Disease control rate
the ratio of patients whose efficiency evaluation is CR or PR or SD
Time frame: AEs (Adverse events) should be recorded during the study period and six months after last IMP administration
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