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Article History

Accepted: 3 December 2024

First Online: 13 January 2025

Declarations

:

: This study was funded by HUTCHMED Limited and Innovent Biologics, Inc. HUTCHMED Limited was involved throughout the study, including in the study design, data collection, data analysis, data interpretation, and the writing of the report. Innovent Biologics, Inc. provided the investigational medicinal product (sintilimab), but had no role in the above procedures.

: Puhan Lu, Haiyan Shi, Keyan Chen, Panfeng Tan, Songhua Fan, Michael Shi, and Weiguo Su are employees of HUTCHMED Limited. Hua Xu, Dingwei Ye, Xin Yao, Zhisong He, Hong Luo, Guiling Li, Jianming Guo, Lei Diao, Yu Fan, Yuan Li, Jiquan Fan, and Xiaoyi Hu declare that they have no conflicts of interests that might be relevant to the contents of this manuscript.

: The statistical analysis plan and clinical study report can be obtained by contacting the corresponding author. Individual participant data will not be made available.

: This study was approved by ethics committees and conducted in accordance with the Declaration of Helsinki, good clinical practice, and applicable regulations and guidelines. Details of the ethics committees are found in the electronic supplementary material.

: All enrolled patients provided written informed consent for study participation.

: Not applicable.

: Not applicable.

: Hua Xu, Xin Yao, Zhisong He, Hong Luo, Guiling Li, Jianming Guo, Lei Diao, Yu Fan, Yuan Li, Jiquan Fan, Xiaoyi Hu, Dingwei Ye contributed to the conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, software, supervision, validation, writing, review, and editing. Puhan Lu, Haiyan Shi, Keyan Chen, Panfeng Tan, Songhua Fan, Michael Shi, and Weiguo Su contributed to the conceptualization, formal analysis, funding acquisition, investigation, project administration, resources, writing, review, and editing.