Sodium glycididazole combined with definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma: A multicenter randomized clinical trial.

IF 2.1 Q4 Medicine

Precision Radiation Oncology Pub Date : 2026-02-25 eCollection Date: 2026-03-01 DOI:10.1002/pro6.70052

Xiaoling Li, Hanxi Zhao, Peng Xie, Wanqi Zhu, Liping Liu, Peipei Wu, Yanxing Sheng, Chuandong Wang, Yipeng Song, Xiangjiao Meng, Jiandong Zhang, Ligang Xing

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Abstract

Purpose: To evaluate the efficacy and safety of the radiosensitizer-sodium glycididazole (CMNa) combined with definitive concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with locally advanced esophageal squamous cell carcinoma (ESCC).

Methods: Patients were enrolled and randomly assigned to receive CMNa plus CCRT (CMNa group) or CCRT alone (control group). CMNa (800 mg/m²) was administered three times per week during radiotherapy (1.8-2.0 Gy per fraction, total dose of 59.4-60.0 Gy). The primary endpoint was the objective response rate (ORR) and the secondary endpoint was the incidence of adverse events.

Results: Sixty-six patients with ESCC were recruited from six medical centers between 2016 and 2018. The ORRs in the CMNa and control groups were 90.32% and 68.57%, respectively (χ² = 4.925, p = 0.0265). The proportions of patients with a complete response were 8/31 (25.81%) and 8/35 (22.86%) in the CMNa and control groups, respectively. The combination of CMNa and CCRT did not increase the incidence of acute or late adverse effects.

Conclusion: CMNa combined with CCRT improved the ORR in patients with ESCC compared with CCRT alone without increasing treatment-related toxicity.

Trial registration: The protocol was registered at Clinicaltrials.gov (www.clinicaltrials.gov) (Clinical Trials ID: NCT02721563). Study Registration Date: March 29, 2016.

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甘氨双唑钠联合明确放化疗治疗食管鳞状细胞癌：一项多中心随机临床试验

目的：评价放射增敏剂-甘氨双唑钠（CMNa）联合确定性同步放化疗（CCRT）与单独CCRT治疗局部晚期食管鳞状细胞癌（ESCC）患者的疗效和安全性。方法：将患者随机分为CMNa + CCRT组（CMNa组）和CCRT组（对照组）。放疗期间给予CMNa (800 mg/m2)，每周3次（每份1.8-2.0 Gy，总剂量59.4-60.0 Gy）。主要终点为客观缓解率（ORR），次要终点为不良事件发生率。结果：2016年至2018年间，从6个医疗中心招募了66名ESCC患者。CMNa组和对照组的orr分别为90.32%和68.57% （χ2 = 4.925, p = 0.0265）。CMNa组和对照组患者完全缓解的比例分别为8/31（25.81%）和8/35（22.86%）。ccmna与CCRT联合使用未增加急性或晚期不良反应的发生率。结论：与CCRT单独治疗相比，ccmna联合CCRT可改善ESCC患者的ORR，且未增加治疗相关毒性。试验注册：该方案已在Clinicaltrials.gov （www.clinicaltrials.gov）注册（临床试验ID: NCT02721563）。研究注册日期：2016年3月29日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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