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Brief Title: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
Official Title: Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression
Study ID: NCT04714190
Brief Summary: This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.
Detailed Description: This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Affiliated Hospital of Hebei University, Baoding, , China
China-Japan Friendship Hospital, Beijing, , China
Luhe Hospital Affiliated to Capital Medical University, Beijing, , China
Peking University People's Hospital, Beijing, , China
Jilin Provincial Tumor Hospital, Changchun, , China
Xiangya Hospital of Central South University, Changsha, , China
Affiliated Hospital of Chengde Medical College, Chengde, , China
Three Gorges Hospital Affiliated to Chongqing University, Chongqing, , China
Fujian Cancer Hospital, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Southern Hospital of Southern Medical University, Guangzhou, , China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
The Affiliated Tumor Hospital of Harbin Medical University, Harbin, , China
Anhui Cancer Hospital, Hefei, , China
Anhui Provincial Hospital, Hefei, , China
Jinan Central Hospital, Jinan, , China
Shandong Cancer Hospital, Jinan, , China
Affiliated Hospital of Jining Medical College, Jining, , China
The First People's Hospital of Jining City, Jining, , China
Lanzhou University Second Hospital, Lanzhou, , China
Linyi Tumor Hospital, Linyi, , China
Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, , China
Jiangsu Cancer Hospital, Nanjing, , China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, , China
Qingdao University Hospital, Qingdao, , China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, , China
Shanghai Changhai Hospital, Shanghai, , China
Zhongshan Hospital Affiliated to Fudan University, Shanghai, , China
Cancer Hospital Affiliated to Shantou University Medical College, Shantou, , China
Liaoning Cancer Hospital, Shenyang, , China
Shenzhen People's Hospital, Shenzhen, , China
The First Affiliated Hospital of Soochow University, Suzhou, , China
Shanxi Cancer Hospital, Taiyuan, , China
Tianjin Cancer Hospital, Tianjin, , China
Weifang People's Hospital, Weifang, , China
Weihai Municipal Hospital, Weihai, , China
Huazhong University of Science Tongji Hospital, Tongji Medical College, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Affiliated Hospital of Qinghai University, Xining, , China
Qinghai Provincial People's Hospital, Xining, , China
The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, , China
Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Xuzhou Central Hospital, Xuzhou, , China
Subei People's Hospital of Jiangsu Province, Yangzhou, , China
Yantai Yuhuangding Hospital, Yantai, , China
Henan Cancer Hospital, Zhengzhou, , China