Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
This study is a two-stage design. Stage 1
The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus
S-1 after one course of treatment as 3+1 design:
nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows, Treatment
should be repeated every 3 weeks: Treatment arm A：125 mg /m2; Treatment arm B：100 mg /m2;
Treatment arm C: 80 mg /m2; S-1 should be given orally twice a day as follows for 14
consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. BSA
＜ 1.5 m2，40mg，bid;BSA ≥ 1.5 m2，50mg，bid.
The investigator should determine whether to continue the original regimen; compare the
safety and pharmacokinetic results with original profile of combination therapy to select
the best therapy programs (RD, recommended dose).
Stage 2 According to two-stage design (Simon,1989), re-entry subjects to the recommended
dose group to a total of 25 valid cases. If 11 patients achieve response, then enter the
second phase of total 66 patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
during the treatment in the hosptital,an expected average of 3 weeks
China: Food and Drug Administration