详情页 - 河北医科大学第四医院机构库

当前位置：首页 > 详情页

Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial

8| 导出 | 链接全文 |

文献详情

资源类型：

WOS体系：

Pubmed体系：

收录情况： ◇ SCIE

作者：

机构： [1]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China [2]Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China [3]Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China [4]Department of Radiation Oncology, Henan Cancer Hospital,Zhengzhou, China [5]Department of Radiation Oncology, The First Hospital of China Medical University, Shenyang, China [6]Department of Radiation Oncology, Jiangsu CancerHospital, Nanjing, China [7]Department of Radiation Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi, China [8]Department of Radiation Oncology, Guangxi MedicalUniversity Cancer Hospital, Nanning, China [9]Department of Radiation Oncology, Beijing Cancer Hospital, Beijing, China [10]Department of Radiation Oncology, Affiliated Hospitalof Jiangsu University, Zhenjiang, China [11]Department of Radiation Oncology, The First Hospital of Zhejiang Province, Hangzhou, China [12]Department of Oncology, SubeiPeople’s Hospital, Yangzhou University, Yangzhou, China [13]Department of Medical Oncology, Henan Provincial Nanyang Central Hospital, Nanyang, China [14]Department ofRadiation Oncology, Renji Hospital Shanghai jiaotong university School of medicine, Shanghai, China [15]Department of Radiation Oncology, The First Affiliated Hospital ofZhengzhou University, Zhengzhou, China [16]Department of Oncology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China [17]Department of RadiationOncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

出处：

DOI：

ISSN：

摘要：

This prospectively randomised, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial was conducted to assess the efficacy and safety profile of nimotuzumab (nimo) plus concurrent chemo-radiotherapy (CCRT) in patients with unresectable locally advanced ESCC.Patients were randomly assigned (1:1) to receive CCRT plus nimotuzumab or placebo. The primary endpoint was overall survival (OS). In addition, interim analysis for short-term response rate was pre-defined.A total of 201 patients were randomised into two groups. Eighty patients in the nimo group and eighty-two in the placebo group were evaluable. Three to six months after treatment, 26 (32.5%) patients achieved complete response (CR) in the nimo group, and 10 (12.2%) in the placebo group (P = 0.002). The ORR of the nimo group was significantly higher than the placebo group (93.8% vs. 72.0%, P < 0.001). The two groups' grade 3-5 adverse drug reactions were 11.1% vs. 10.9% (P > 0.05).Nimotuzumab, in combination with chemo-radiotherapy, increased the CRR and ORR with a good safety profile. The OS is needed to be followed and finally analysed.NCT02409186.© 2023. The Author(s), under exclusive licence to Springer Nature Limited.

语种：

被引次数：

WOS：

PubmedID：

中科院分区：

出版当年[2023]版：

大类 | 1 区

医学

小类 | 2 区肿瘤学

最新[2025]版：

大类 | 2 区

医学

小类 | 2 区肿瘤学

JCR分区：

出版当年[2023]版：

Q1 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 6.4 最新[2023版] 8.1 最新五年平均 6.4 出版当年[2023版] 8.1 出版当年五年平均 8.8 出版前一年[2022版]

第一作者：

第一作者机构： [1]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China

通讯作者：

推荐引用方式(GB/T 7714)：

APA：

MLA：