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. 2020 Nov 10;17(5):491–501. doi: 10.2217/fon-2020-0737

Table 1. . Study treatments.

Treatment Dose Frequency Route of administration Dosing time of each 3-week cycle
Pembrolizumab 200 mg Q3W IV infusion Day 1 of each cycle
Placebo (normal saline) NA Q3W IV infusion Day 1 of each cycle
FP
– Cisplatin 80 mg/m2 Q3W IV infusion Day 1 of each cycle
– 5-Fluorouracil 800 mg/m2/day Continuous IV infusion Days 1–5 of each cycle
CAPOX
– Oxaliplatin 130 mg/m2 Q3W IV infusion Day 1 of each cycle
– Capecitabine 1000 mg/m2 BID Oral Days 1–14 of each cycle
SOX§
– S-1 <1.25 m2; BSA: 40 mg
1.25 to <1.5 m2; BSA: 50 mg
≥1.5 m2; BSA: 60 mg
BID Oral Days 1–14 of each cycle
– Oxaliplatin 130 mg/m2 Q3W IV infusion Day 1 of each cycle
– Trastuzumab 8 mg/kg loading dose
6 mg/kg maintenance dose
Q3W IV infusion Day 1 of each cycle

Choice of chemotherapy backbone to be decided by the investigator before randomization.

Duration of cisplatin treatment may be capped at 6 cycles per local country guidelines; however, treatment with 5-fluorouracil may continue per protocol.

§

SOX received only by patients in the Japan-specific cohort.

Body surface area to be calculated per local guidance.

BID: Twice daily; CAPOX: Capecitabine + oxaliplatin; FP: 5-Fluorouracil + cisplatin; IV: Intravenous; Q3W: Every 3 weeks; SOX: S-1 + oxaliplatin.