Wu 2015.

Methods	Pilot randomiSed‐controlled study
Participants	"158 participants were initially screened, of whom 86 were excluded. Of these 86 patients, 73 did not fulfill the study criteria and 13 declined to participate. The remaining 72 patients (36 treated with SC and 36 treated with C) were entered into the study" "The mean age of the patients was 64.1 years in the SC group and 62.7 years in the C group. The performance status was 0 for 41.7% of patients treated with SC and 44.4% of patients treated with C and it was 1 for 58.3% of patients treated with SC and 44.4% of patients treated with C. The primary lesion was 55.6% in the SC group and 50.0% in the C group. Histological types were intestinal (58.3% in the SC group and 61.1% in the C group), diffuse (36.1% in the SC group and 30.6% in the C group), and others (5.6% in the SC group and 8.3% in the C group). The diagnosis was AGC (86.1% in the SC group and 83.3% in the C group) and relapse gastric cancer (13.9% in the SC group and 16.7% in the C group)."
Interventions	"Patients in the C group received cisplatin 75 mg/m2 intravenously over 1–3 h on day 1 and then at 4‐week intervals. In addition to receiving the same intervention as the C group, patients in the SC group were also administered S‐1 on days 1–14 of a 21‐day cycle. The daily dose of S‐1 was assigned according to the body surface area as follows: less than 1.25 m2, 40 mg two times daily; more than or equal to 1.25 m2 and less than 1.5 m2, 50 mg two times daily; and more than or equal to 1.5 m2, 60 mg two times daily."
Outcomes	OS PFS Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patients were stratified using the block randomization method of the SAS package (version 8.2; SAS Institute Inc., Cary, North Carolina, USA) by a statistician with no clinical involvement in this study"
Allocation concealment (selection bias)	Low risk	"The allocation was concealed in sequentially numbered, opaque, sealed envelopes containing the randomization assignments"
Incomplete outcome data (attrition bias) efficacy	Low risk	All participants could undergo evaluations for efficacy and safety.
Incomplete outcome data (attrition bias) safety	Low risk	All participants could undergo evaluations for efficacy and safety.
Selective reporting (reporting bias)	High risk	Overall response rates were compared although it did not appear to be prespecified. Furthermore, details of how response was assessed were not provided.
Other bias	High risk	Study did not clearly specify minimum required sample size ‐ "Sample size was calculated on the basis of an expected 15% difference between the two groups, with 80% power and a two‐sided [alpha] value of 0.05" Comments from statistician BCT:The paper is not clear about how the sample size is being estimated. In particular, we do not have information on the HR or the survival probability of the control group. I assume the 15% difference refers to absolute difference. I try to work out this difference from the KM curve of Fig 2. If we assume a 1 year estimate, then the survival probability is approx. 25% vs 40% (HR approx. 0.66). If we assume a 0.5 year estimate, then the survival probability is 75% vs 90% (HR approx. 0.37). This corresponds to a total sample size of about 300 and 200 respectively, assuming a two‐sided test at 5% level and a power of 80%. If we estimate the HR from the median OS that is reported, the HR is approx. 0.8, and so we would expect an even larger sample size.
Blinded review of CT/MRI‐scans?	Unclear risk	Not stated