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Article History

Received: 3 September 2024

Accepted: 26 August 2025

First Online: 8 October 2025

Declarations

:

: The study protocol and all amendments were approved by the Ethics Committees of all participating hospitals: the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (17–163/1419); the 307th Hospital of the Chinese People’s Liberation Army (2017–12-55–1); Peking University Cancer Hospital and Institute (2018YW16 and 2020YW126); the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital (2019-Drug Review []); Fudan University Shanghai Cancer Center (1808189–1); the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital (2019087); the Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital (2019036); the First Hospital of China Medical University (2020YL057); Institute of Oncology, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital (20190544); Cancer Center, the First Bethune Hospital of Jilin University (19Y081-001); Tianjin Medical University Cancer Institute and Hospital (E2019151); the Third Hospital of Nanchang (Drug (2020) Ethical No.32); Sichuan Cancer Hospital (SCCHEC-01A-2020–039); Sun Yat-sen Memorial Hospital, Sun Yat-sen University (2020-YW-093). All procedures were conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. All patients provided written informed consent before being enrolled in the trial, which was registered with ClinicalTrials.gov (identification ID: NCT04539496).

: Not applicable.

: LMX, XHD, MML, YPM, FL and LW are employees of Xuanzhu Biopharmaceutical Co., Ltd. BHX reported receiving consulting fees and payment for lectures from AstraZeneca and Novartis outside the submitted work. The remaining authors declare no potential competing interests.