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Background <p>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.</p> Methods <p>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.</p> Results <p>The 63 patients in this study completed neoadjuvant therapy followed by esophagectomy (CIT [<i>n</i> = 42] or CRT [<i>n</i> = 21]). The pCR rate was numerically higher with CRT than with CIT (52.4 % vs 31.0 %; <i>p</i> = 0.110). Nodal clearance was comparable (ypN0: 85.7 % vs 78.6 %; <i>p</i> = 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 (<i>p</i> = 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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2026年6月27日

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  • 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

摘要

Background

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.

Methods

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.

Results

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.

Conclusions

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.