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Brief Title: Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
Official Title: A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
Study ID: NCT06155383
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Detailed Description: This is an open-label, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing (immunohistochemical 1+, 2+, 3+) resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Yunnan Cancer Hospital, Kunming, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Gansu Wuwei Tumour Hospital, Wuwei, Gansu, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Shandong Cancer Hospital & Institute, Jinan, Shangdong, China
Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, China
Name: Jianmin Fang, Ph.D
Affiliation: RemeGen Co., Ltd.
Role: STUDY_DIRECTOR