Efficacy and safety of a novel anti‐HER2 therapeutic antibody RC48 in patients with HER2‐overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single‐arm phase II study

Author:

Peng Zhi1,Liu Tianshu2,Wei Jia3,Wang Airong4,He Yifu5,Yang Liuzhong6,Zhang Xizhi7,Fan Nanfeng8,Luo Suxia9,Li Zhen10,Gu Kangsheng11,Lu Jianwei12,Xu Jianming13,Fan Qingxia14,Xu Ruihua15,Zhang Liangming16,Li Enxiao17,Sun Yuping18,Yu Guohua19,Bai Chunmei20,Liu Yong21,Zeng Jiangzheng22,Ying Jieer23,Liang Xinjun24,Xu Nong25,Gao Chao26,Shu Yongqian27ORCID,Ma Dong28,Dai Guanghai29,Li Shengmian30,Deng Ting31,Cui Yuehong2,Fang Jianmin32,Ba Yi31ORCID,Shen Lin1

Affiliation:

1. Department of Gastrointestinal Oncology Key Laboratory of Cancinogenesis and Translational Research (Ministry of Education) Peking University Cancer Hospital & Institute Beijing 100142 P. R. China

2. Department of Gastrointestinal Oncology Affiliated Zhongshan Hospital of Fudan University Shanghai 200032 P. R. China

3. Department of Oncology Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu 210008 P. R. China

4. Department of Oncology Weihai Municipal Hospital Weihai Shandong 264299 P. R. China

5. Department of Oncology Anhui Provincial Cancer Hospital Hefei Anhui 230031 P. R. China

6. Department of Oncology The First Affiliated Hospital of Xinxiang Medical College Xinxiang Henan 453100 P. R. China

7. Department of Oncology Subei People's Hospital Yangzhou Jiangsu 225009 P. R. China

8. Department of Abdominal Oncology Fujian Provincial Cancer Hospital Fuzhou Fujian 350014 P. R. China

9. Department of Gastrointestinal Oncology Henan Cancer Hospital Zhengzhou Henan 450003 P. R. China

10. Department of Oncology Linyi Cancer Hospital Linyi Shandong 276002 P. R. China

11. Department of Oncology The First Affiliated Hospital of Anhui Medical University Hefei Anhui 230022 P. R. China

12. Department of Oncology Jiangsu Cancer Hospital Nanjing Jiangsu 210009 P. R. China

13. Department of Oncology The Fifth Medical Center of PLA General Hospital Beijing 100039 P. R. China

14. Department of Oncology The First Affiliated Hospital of Zhengzhou Zhengzhou Henan 450099 P. R. China

15. Department of Oncology Sun Yat‐sen University Cancer Center Guangzhou Guangdong 510060 P. R. China

16. Department of Oncology Yantai Yuhuangding Hospital Yantai Shandong 264099 P. R. China

17. Department of Oncology The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi 710061 P. R. China

18. Department of Oncology Jinan Central Hospital Jinan Shandong 250013 P. R. China

19. Department of Oncology Weifang People's Hospital Weifang Shandong 261041 P. R. China

20. Department of Oncology Peking Union Medical College Hospital Beijing 100005 P. R. China

21. Department of Oncology Xuzhou Central Hospital Xuzhou Jiangsu 221009 P. R. China

22. Department of Oncology The First Affiliated Hospital of Hainan Hospital Haikou Hainan 570102 P. R. China

23. Department of Abdominal Oncology Zhejiang Cancer Hospital Hangzhou Zhejiang 310005 P. R. China

24. Department of Oncology Hubei Cancer Hospital Wuhan Hubei 430079 P. R. China

25. Department of Oncology The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang 310003 P. R. China

26. Department of Oncology The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu 221004 P. R. China

27. Department of Oncology Jiangsu Province Hospital Nanjing Jiangsu 210029 P. R. China

28. Department of Oncology Guangdong Provincial People's Hospital Guangzhou Guangdong 510080 P. R. China

29. Department of Oncology Chinese PLA General Hospital Beijing 100036 P. R. China

30. Department of Gastrointestinal Oncology The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei 050011 P. R. China

31. Department of Gastrointestinal Oncology Tianjin Medical University Cancer Institute and Hospital Tianjin 300181 P. R. China

32. RemeGen, Ltd. Beijing 100020 P. R. China

Funder

National Natural Science Foundation of China

Publisher

Wiley

Subject

Cancer Research,Oncology

Reference28 articles.

1. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries;Sung H;CA Cancer J Clin,2020

2. Report of cancer epidemiology in China, 2015;Zheng RS;Zhonghua Zhong Liu Za Zhi,2019

3. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer

4. NCCN Clinical Practice Guidelines in Oncology: Gastric cancer(version 2.2020).https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf

5. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

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