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Article History

Received: 19 January 2025

Accepted: 5 February 2025

First Online: 28 February 2025

Declarations

:

: This study is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. The protocol has been reviewed and approved by the Ethics Committee of West China Hospital (Approval No. 2023-71) and is supposed to be approved by all the participating institutes. The current protocol version is V5.0/2023-01-10. The study has been registered with the U.S. National Institutes of Health (clinicaltrials.gov) under registration number NCT06427005. Written informed consent will be obtained from all participants prior to enrollment, and their confidentiality will be strictly maintained throughout the study.

: The authors declare no competing interests.

: This is an investigator-initiated and investigator-led trial, sponsored by Beijing Xisike Clinical Oncology Research Foundation. The funders have had no involvement in the design of the trial or the writing of the protocol, and will not participate in data collection, analysis, or interpretation during the study. The corresponding author has full access to all study documentation and bears the final responsibility for the decision to submit the protocol for publication.