camrelizumab alone (n=228) vs. Standard of Care (SoC) (n=220)
randomized controlled trial
camrelizumab
camrelizumab 200 mg every 2 week. Dose reduction of camrelizumab was not permitted.
docetaxel or irinotecan
chemotherapy with docetaxel (75 mg/m2 every 3 weeks) or irinotecan (180 mg/m2 every 2 weeks) : docetaxel (19.5%) or irinotecan(80.5%)
mEC - 2nd line (L2)
Asian only
open label
43 hospitals in China
p3 /one sided and Interim analysis. Only OS at one sided level : 0.025 This study only involves one final analysis of the primary endpoint OS and the multiplicity issues will not be involved
Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy
ATTRACTION-3, 2019 NCT02569242
nivolumab alone (n=210) vs. Standard of Care (SoC) (n=209)
randomized controlled trial
Nivolumab
Nivolumab was administered intravenously over 30 min at a dose of 240 mg every 2 weeks (each cycle was 6 weeks).
ICC Docetaxel/Paclitaxel
Paclitaxel and docetaxel were administered intravenously for at least 60 min; paclitaxel at 100 mg/m² once per week for 6 weeks followed by 1 week off (each cycle was 7 weeks) and docetaxel at 75 mg/m² every 3 weeks (each cycle was 3 weeks). paclitaxel (68.9%) docetaxel (31.1%)
Dose reductions were allowed for paclitaxel and docetaxel for toxicities prespecified in the protocol under dose reduction criteria. Dose reductions were not permitted in the nivolumab group.
mEC - 2nd line (L2)
95.7 %asian patients
open design
90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and
P3/ two sided and no interim analysis (cancelled). Hierarchical testing procedure with secondary endpoint : OS then ORR then PFS
Nivolumab was associated with a significant improvement in overall survival and a favourable safety profile compared with chemotherapy in previously treated patients with advanced oesophageal squamous cell carcinoma
KEYNOTE-181, 2020 NCT02564263
pembrolizumab alone (n=314) vs. Standard of Care (SoC) (n=314)
randomized controlled trial
Pembrolizumab
pembrolizumab 200 mg Q3W for up to 2 years
chemotherapy ICC (paclitaxel, docetaxel, or irinotecan)
investigator’s choice chemo of paclitaxel, docetaxel, or irinotecan.paclitaxel 80-100 mg/m on days 1, 8, and 15 Q4W, docetaxel 75 mg/m Q3W, or irinotecan 180 mg/m Q2W.