Nimotuzumab plus concurrent chemo-radiotherapy versus chemo-radiotherapy in unresectable locally advanced esophageal squamous cell carcinoma (ESCC): Interim analysis from a prospective, randomized-controlled, double-blinded, multicenter, and phase III clinical trial (NXCEL1311 Study).

作者：Xue Meng, Anping Zheng, Jun Wang, Jianhua Wang, Guang Li, Jun Zhu, Hu Ma, Xiaodong Zhu, Anhui Shi, Chunhua Dai, Senxiang Yan, Buhai Wang, Zhongyu Qu, Chun Han, Xindong Sun, Ming Ye, Ruitai Fan, Ni yazi Huerxidan, Xiaohong Wang, Jinming Yu · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.2022.40.16_suppl.4016 · 被引用次数：3 · 研究领域：Esophageal Cancer Research and Treatment、Radiopharmaceutical Chemistry and Applications、Lung Cancer Treatments and Mutations

4016 Background: 70% of esophageal carcinoma are unresectable at diagnosis. Despite active clinical research on the treatment of esophageal squamous cell carcinoma (ESCC), the long-term survival rate of advanced patients is still very low, with a 5-year survival rate of 30%-40%. A prospective, randomized-controlled, double-blinded, multicenter, and phase III study (NXCEL1311) was designed to investigate the efficacy and safety of nimotuzumab (anti-EGFR humanized monoclonal antibody;abbreviate,Nimo) plus concurrent chemo-radiotherapy compared with placebo plus chemo-radiotherapy in unresectable locally advanced ESCC. Methods: Unresectable locally advanced ESCC patients were randomized (1:1) to receive Nimo (400 mg, qw) or placebo in combination with concurrent chemo-radiotherapy (paclitaxel+ cisplatin+3DCRT/IMRT) for seven weeks. Patients were followed for five years.The primary endpoints were OS, and the secondary endpoints included ORR, DCR, PFS. Results: 200 patients were assigned to the Nimo group (n = 99) or placebo group (n = 101). An interim analysis was conducted for short term efficacy, i.e secondary endpoints (ORR, DCR) and safety, after completing the 6 months follow-up. The OS events are not enough for analysis. The two groups were comparable on baseline characteristics. Eighty patients in the Nimo group and eighty-two patients in the placebo group were evaluable. The ORR of the Nimo group (75/80, 93.8%) was significantly higher than the placebo group (59/82, 72.0%...