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

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

doi:10.1002/pro6.70052

Precision Radiation Oncology ›› 2026, Vol. 10 ›› Issue (1) :19 -26. DOI: 10.1002/pro6.70052

ORIGINAL ARTICLE

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

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¹. Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

². Department of Radiology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

³. Department of Pathology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

⁴. Department of Radiation Oncology, Jining No.1 People's Hospital, Jining, Shandong, China

⁵. Department of Radiation Oncology, Liaocheng People's Hospital, Liaocheng, Shandong, China

⁶. Department of Radiation Oncology, Anqiu People's Hospital, Anqiu, Shandong, China

⁷. Department of Radiation Oncology, Yantai Yuhuangding Hospital, Yan Tai, Shandong, China

⁸. Department of Radiation Oncology, The First Affiliated Hospial of Shandong First Medical Universit, Shandong Province Qianfoshan Hospital, Jinan, Shandong, China

daisylinjinan@163.com

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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.

Keywords

concurrent chemoradiotherapy / esophageal squamous cell carcinoma / sodium glycididazole

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Xiaoling Li, Hanxi Zhao, Peng Xie, Wanqi Zhu, Liping Liu, Peipei Wu, Yanxing Sheng, Chuandong Wang, Yipeng Song, Xiangjiao Meng, Jiandong Zhang, Ligang Xing. Sodium glycididazole combined with definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma: A multicenter randomized clinical trial. Precision Radiation Oncology, 2026, 10 (1) : 19-26 DOI:10.1002/pro6.70052

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