免疫检查点抑制剂联合化疗方案一线治疗晚期食管鳞癌的临床综合评价指标体系构建OA

Objective:To construct an indicator system for comprehensive clinical evaluation of immune checkpoint inhibitors(ICIs)combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma(ESCC),with reference to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(2021 Trial Version)and the Technical Guidelines for Comprehensive Clinical Evaluation of Antitumor Drugs(2022 Trial Version).Methods:A three-level framework for comprehensive clinical evaluation was initially developed through literature analysis.Two rounds of Delphi expert consultation were conducted to determine the evaluation indicators,and the normalization method and analytic hierarchy process were used to determine the weight coefficient of each indicator,thereby establishing the indicator system for comprehensive clinical evaluation of ICIs combined with chemotherapy as first-line treatment for advanced ESCC.Results:Through multidimensional and multimethod evidence synthesis,an indicator system comprising 6 first-level indicators,18 second-level indicators,and 49 third-level indicators was established.Conclusion:The constructed indicator system for comprehensive clinical evaluation of ICIs combined with chemotherapy as first-line treatment for advanced ESCC has high scientific validity and applicability and may provide a reference for empirical studies on comprehensive clinical evaluation of ICIs and for drug selection.