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Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody

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资源类型：
Pubmed体系：
作者：
Lin Jinguan[1] * ; Qu Song[2] ; Yang Kunyu[3] ; Zhang Tao[4] ; Bai Yuansong[5] ; Wu Jian[6] ; Huang Yanjing[7] ; Fang Meiyu[8] ; Liu Xianling[9] ; Huang Xiaoming[10] ; Chen Nianyong[11] ; Li Zhendong[12] ; Li Weidong[13] ; Zhang Songnan[14] ; Zhang Shurong[15] ; Hu Guangyuan[16] ; Sun Yan[17] ; Chen Xiaohong[15] ; Liu Yanyan[18] ; Jing Shanghua[19] ; Shen Liangfang[20] ; Chang Zhiwei[21] ; Xie Liangzhi[22] ; Gai Wenlin[22] ; Zhou Qiang[22] ; Chen Xinyue[22] ; Yi Jiang[22] ; Guo Ye[23] ;
机构： [1]The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/Hunan Cancer Hospital, Changsha, China [2]Guangxi Medical University Cancer Hospital, Nanning, China [3]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [4]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China [5]The Third Bethune Hospital of Jilin University, Changchun, China [6]Chongqing University Cancer Hospital, Chongqing, China [7]Hainan General Hospital, Haikou, China [8]Zhejiang Cancer Hospital, Hangzhou, China [9]The Second Xiangya Hospital of Central South University, Changsha, China [10]Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China [11]West China Hospital, Sichuan University, Chengdu, China [12]Liaoning Cancer Hospital & Institute, Shenyang, China [13]Afflllated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China [14]Yanbian University Hospital, Yanji, China [15]Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China [16]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [17]Peking University Cancer Hospital, Beijing, China [18]Henan Cancer Hospital, Zhengzhou, China [19]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China [20]Xiangya Hospital of Central South University, Changsha, China [21]The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [22]Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China [23]Shanghai East Hospital, School of Medicine, Tongji University, #1800 Yun Tai Road, Shanghai, 200123, China
出处：
DOI： 10.1016/j.canlet.2025.217513
ISSN：

关键词： Programmed cell death protein 1 Chemotherapy Epidermal growth factor receptor SCT200 Head and neck squamous cell carcinoma

摘要：
Treatment options for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) are limited, especially for patients who progress after immune checkpoint inhibitor (ICI) therapy. This phase Ib study investigates the efficacy and safety of SCT200, an epidermal growth factor receptor (EGFR) antibody, combined with paclitaxel or docetaxel in R/M HNSCC patients who have failed both platinum-based chemotherapy and programmed cell death protein 1 (PD-1) inhibitors. This was a multicenter, open-label study enrolling patients with resistance or intolerance to platinum-based chemotherapy and PD-1 inhibitors. Patients received intravenous SCT200 (6 mg/kg weekly for 12 weeks, followed by 8 mg/kg every two weeks). Paclitaxel (80 mg/m2 weekly) or docetaxel (75 mg/m2 every three weeks) was administered according to the patient's prior paclitaxel treatment history. The primary endpoint was objective response rate (ORR). Thirty patients were included in the efficacy and safety analyses. The ORR was 26.7% (95% confidence interval [CI]: 12.3-45.9). The median progression-free survival (PFS) was 4.1 months (95% CI: 2.7-5.7), and the median overall survival (OS) was 8.7 months (95% CI: 5.0-11.9). For patients receiving SCT200 with docetaxel, median PFS was 5.7 months, and OS was 9.5 months. Common adverse events (AEs) included hypomagnesemia, acneiform dermatitis, and rash. No unexpected safety signals were observed. SCT200 in combination with paclitaxel or docetaxel shows promising efficacy in patients with R/M HNSCC following platinum-based chemotherapy and PD-1 inhibitors, warranting further investigation. ClinicalTrials.gov identifier: NCT05552807.Copyright © 2025. Published by Elsevier B.V.

基金：
This work was supported by the National Science and Technology Major Projects of China (2019ZX09732-001).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
第一作者：
第一作者机构： [1]The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/Hunan Cancer Hospital, Changsha, China
通讯作者：
推荐引用方式(GB/T 7714)：
Lin Jinguan,Qu Song,Yang Kunyu,et al.Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody[J].Cancer Letters.2025,217513.doi:10.1016/j.canlet.2025.217513.
APA：
Lin Jinguan,Qu Song,Yang Kunyu,Zhang Tao,Bai Yuansong...&Guo Ye.(2025).Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody.Cancer Letters,,
MLA：
Lin Jinguan,et al."Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody".Cancer Letters .(2025):217513

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