Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 28, 2023; 29(24): 3871-3882
Published online Jun 28, 2023. doi: 10.3748/wjg.v29.i24.3871
Stereotactic body radiotherapy combined with sintilimab in patients with recurrent or oligometastatic hepatocellular carcinoma: A phase II clinical trial
Yi-Xing Chen, Ping Yang, Shi-Suo Du, Yuan Zhuang, Cheng Huang, Yong Hu, Wen-Chao Zhu, Yi-Yi Yu, Tian-Shu Liu, Zhao-Chong Zeng
Yi-Xing Chen, Ping Yang, Shi-Suo Du, Yuan Zhuang, Yong Hu, Wen-Chao Zhu, Zhao-Chong Zeng, Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Cheng Huang, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Yi-Yi Yu, Tian-Shu Liu, Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Author contributions: Zeng ZC, Liu TS, Chen YX, Du SS, and Yu YY contributed to the conception and study design; Chen YX, Yang P, Zhuang Y, Huang C, Hu Y, and Zhu WC contributed to the investigation and data curation; Chen YX, Zeng ZC, and Liu TS performed the data analysis and interpretation; Chen YX wrote the original draft; Zeng ZC, Liu TS, Chen YX, and Du SS wrote the review and editing; Liu TS and Zeng ZC contributed equally to this work. All authors reviewed and approved the final draft of the manuscript.
Supported by The Ministry of Science and Technology of The People's Republic of China, No. 2022YFC2503700, and No. 2022YFC2503704.
Institutional review board statement: The Medical Ethics Committee of Zhongshan Hospital, Fudan University, approved this study (B2019-010R), which was conducted in accordance with the standards of Good Clinical Practice and the Declaration of Helsinki. All patients consented to participate after being informed of the study’s purpose.
Clinical trial registration statement: This was a single-arm, open-label, single-center, phase II trial registered with ClinicalTrials.gov (NCT03857815).
Informed consent statement: All patients consented to participate after being informed of the study’s purpose.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zhao-Chong Zeng, PhD, Professor, Department of Radiation Oncology, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai 200032, China. zeng.zhaochong@zs-hospital.sh.cn
Received: March 26, 2023
Peer-review started: March 26, 2023
First decision: April 26, 2023
Revised: May 6, 2023
Accepted: May 30, 2023
Article in press: May 30, 2023
Published online: June 28, 2023
Processing time: 94 Days and 9.2 Hours
Core Tip

Core Tip: In this single-arm phase II trial, stereotactic body radiotherapy (SBRT) plus sintilimab showed outstanding progression-free survival and objective response rate in the treatment of recurrent or oligometastatic hepatocellular carcinoma. Moreover, the combined use of SBRT and sintilimab is safe and tolerable. Patients can recover rapidly from radiotherapy-induced decreases in lymphocyte counts. This result suggests that SBRT combined with sintilimab may be a new treatment option for patients with recurrent or oligometastatic hepatocellular carcinoma.