Clinical Trial Protocol

Gemcitabine and cisplatin or oxaliplatin chemotherapy combined with atezolizumab plus bevacizumab for advanced biliary tract cancers: a single-arm trial

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Hong-Ming Yu

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Yan-Jun Xiang

https://orcid.org/0000-0002-7378-6724

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Yu-Qiang Cheng

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Qian-Zhi Ni

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

CAS Key Laboratory of Nutrition, Metabolism & Food Safety, Shanghai Institute of Nutrition & Health, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Shanghai, 200031, China

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Wei-Xing Guo

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Jie Shi

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Shuang Feng

Department of Radiotherapy, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Jian Zhai

Department II of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Shu-Qun Cheng

*Author for correspondence: Tel.: +86 218 187 5251;

E-mail Address: chengshuqun@smmu.edu.cn

https://orcid.org/0000-0002-6098-8028

Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 200433, China

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Published Online:3 May 2023https://doi.org/10.2217/fon-2022-0189

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Abstract

Advanced biliary tract cancer (BTC) has a poor prognosis, even after combined chemotherapy of gemcitabine and oxaliplatin (GEMOX). To investigate the efficacy and safety of GEMOX chemotherapy combining atezolizumab and bevacizumab in advanced BTC, the authors designed an open-label, single-arm, phase II clinical trial and will enroll patients with stage IV BTC. The participants will receive GEMOX chemotherapy combined with atezolizumab plus bevacizumab. The primary end point is objective response rate; the secondary end points are overall survival, disease control rate, progression-free survival, time to progression, duration of response and safety. The results of this trial are expected to provide novel, safe and effective treatment options for patients with advanced BTC, which could further improve their prognosis.

Clinical Trial Registration: ChiCTR2100049830 (ChiCTR.org).

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 19, No. 15

Supplemental Materials

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History

Received 22 February 2023

Accepted 7 March 2023

Published online 3 May 2023

Published in print May 2023

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Keywords

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/fon-2022-0189

Author contributions

K Wang and H-M Yu drafted the manuscript. K Wang, H-M Yu and Y-J Xiang contributed equally to this work. S-Q Cheng, K Wang, H-M Yu and Y-J Xiang designed the trial. Y-J Xiang, Y-Q Cheng, Q-Z Ni, W-X Guo, J Shi, S Feng and J Zhai are responsible for planning the data analysis and analyzing the data resulting from the trial. All named authors adhere to the authorship guidelines of trials. All authors have agreed to publication. All authors read and approved the final manuscript.

Acknowledgments

The authors would like to thank the patients, their families and all the investigators who will participate in the study.

Financial & competing interests disclosure

This work was supported by the Clinical Research Plan of SHDC (No. SHDC2020CR1004A), the State Key Program of National Natural Science Foundation of China (No. 81730097), the National Natural Science Foundation of China (no. 82072618) and the Science and Technology Commission Foundation of Shanghai Municipality (no. 19411967300). The fundings have no roles in the design of the study or collection, analysis and interpretation of data or in writing the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent will be obtained from the participants involved.

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