...the expression rate of PD-1+ Treg cells tended to be higher in non-responders than in responders (15.4 cells/mm2 vs 4.4 cells/mm2, p=0.057). In addition, the PD-1 positivity rate of Treg cells to CD8+ T cells was significantly higher in non-responders than in responders (0.69 vs 0.17, p=0.037). PFS was significantly longer in the low expression group with a PD-1 positivity rate of Tregs to CD8+ T cells below the median of 0.56 than in the high expression group (median PFS: 3.3 months vs 1.8 months; hazard ratio [95%CI]: 0.56 [0.34-0.92], p=0.02)....The expression rate of PD-1+Treg cells in the tumor environment and the balance of PD-1 expression between CD8+T cells and Treg cells is a new promising biomarker for predicting the efficacy of nivolumab in advanced ESCC patients.