Objective:To explore the role of regulatory T cells(Tregs)in evaluating the anti-PD1 efficacy in patients with advanced hepatocellular carcinoma(HCC).Methods:25 patients with advanced hepatocellular carcinoma were selected,who were treated in the Department of Oncology,and 25 healthy controls during the same period were selected.We compared the ratio of peripheral blood immune cells between the two groups.The ELISA assay was used to detect the IL-10 level in peripheral blood of 25 HCC patients.Based on HCC transcriptional data,the correlation between Tregs and the immunosuppressive molecules PD1 and PD-L1 was evaluated.The impact of peripheral blood Tregs and IL-10 on anti-PD1 efficacy was analyzed in 14 patients treated with sintilimab and bevacizumab.Results:The ratio of Tregs and the proportion of effector Tregs in peripheral blood were significantly increased in patients with advanced HCC(P<0.001),compared to healthy people.Further research found that the proportion of Tregs in the patient's peripheral blood was positively correlated with the serum IL-10 content.Bioinformatics analysis revealed that the expression of Tregs-related genes CD25 and FOXP3,as well as IL-10,was positively correlated with the expression of PD1 and PD-L1.Meanwhile,we found that the proportion of effector Tregs and IL-10 content of the peripheral blood were positively correlated with the patient's tumor size.Among 14 patients treated with anti-PD1,the proportion of effector Tregs and the serum IL-10 content of peripheral blood before treatment in patients with disease remission were significantly lower than those in patients with disease progression.Conclusion:The proportion of effector Tregs and serum IL-10 content in peripheral blood are increased in patients with advanced HCC and are negatively correlated with the anti-PD1 efficacy,suggesting that the proportion of Tregs and IL-10 content in the peripheral blood can be used to evaluate the anti-PD1 efficacy in advanced HCC patients.