Tislelizumab for consolidation therapy in patients with pathologically residual Esophageal Squamous Cell Carcinoma after definitive concurrent Chemoradiotherapy: a multicenter, randomized, controlled phase II trial

替雷利珠单抗用于根治性同步放化疗后病理残留食管鳞状细胞癌患者的巩固治疗:一项多中心、随机、对照 II 期试验

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Abstract

Although concurrent Chemoradiotherapy (cCRT) is presently the standard intervention for patients with inoperable, locally advanced Esophageal Squamous Cell Carcinoma (ESCC), it has been associated with poor long-term survival outcomes. Notably, Immune Checkpoint Inhibitors (ICIs) improve the long-term survival of Esophageal Cancer (EC) patients, with manageable Adverse Effects (AEs). Herein, 90 patients with residual pathology after radical simultaneous Radiotherapy (RT) for inoperable/refused-to-operate ESCC were enrolled and randomized into two treatment groups (Chemotherapy+immunotherapy and chemotherapy alone) in a 2:1 ratio. This study will also discuss the value of immunotherapy in improving long-term survival outcomes in patients with pathological residuals after concurrent RT for locally advanced, inoperable ESCC.Clinical trial registration: http://www.chictr.org.cn/identifier is ChiCTR2200063345.

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