A Prospective Multicenter Comparative Cohort Study of Neoadjuvant Sintilimab Plus Chemotherapy and Chemoradiotherapy in Resectable Clinical Node-Positive Esophageal Squamous Cell Carcinoma.

Authors

Aizemaiti Rusidanmu, Kun Zhou, Xingxin Zhu, Difan Zheng, Zhengliang Tu, Haiping Jiang, Rong Yang, Kanfeng Liu, Huifang Zhang, Xianghua Ye, Haogang Yu, Huanming Yu, Pengliang Xu, Shengxu Zhi, Jianfeng Jing, Xuhui Wu, Gongzhi Wu, Chongxiong Peng, Xuyang Peng, Bin Huang, Yonghong Zheng, Peng Ye

Published in

Annals of surgical oncology. Jun 27, 2026. Epub Jun 27, 2026.

Abstract

Neoadjuvant chemoradiotherapy (CRT) remains the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC), although distant recurrence continues to limit long-term survival. Neoadjuvant chemoimmunotherapy (CIT) has emerged as a potential systemic-focused alternative. This prospective multicenter study explored the comparative outcomes of neoadjuvant sintilimab plus chemotherapy versus CRT in resectable, clinical node-positive ESCC.
Consecutive adults with resectable, clinical node-positive (cN+) ESCC were enrolled across four academic centers. The patients received neoadjuvant sintilimab plus platinum-based chemotherapy (CIT) or standard CRT according to predefined institutional pathways in a nonrandomized design (2:1 enrollment). The primary endpoint was pathologic complete response (pCR). The secondary endpoints included nodal downstaging, perioperative outcomes, disease-free survival (DFS), overall survival (OS), and exploratory analyses of pretreatment inflammatory biomarkers.
The 63 patients in this study completed neoadjuvant therapy followed by esophagectomy (CIT [n = 42] or CRT [n = 21]). The pCR rate was numerically higher with CRT than with CIT (52.4 % vs 31.0 %; p = 0.110). Nodal clearance was comparable (ypN0: 85.7 % vs 78.6 %; p = 0.735) with high R0 resection rates in both groups. During a median follow-up period of approximately 22 months, DFS did not differ significantly, whereas OS showed separation on unadjusted Kaplan-Meier analysis (p = 0.04, log-rank). Exploratory analyses showed no significant associations between pretreatment inflammatory biomarkers (neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], platelet-to-lymphocyte ratio [PLR], systemic immune-inflammation index [SII]) and pathologic response. Higher baseline SII was associated with OS in unadjusted comparisons.
In this prospective nonrandomized cohort of clinical node-positive ESCC, CIT achieved nodal downstaging and R0 resection comparable with CRT but lower pCR. The observed survival difference should be interpreted cautiously and warrants validation in randomized trials.

PMID:
42365159
Bibliographic data and abstract were imported from PubMed on 28 Jun 2026.

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