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

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::

• atezolizumab
• bevacizumab
• biliary tract cancers
• gemcitabine
• oxaliplatin

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.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.

Notes

a. Medical history and treatment history: including the disease staging for initial diagnosis, tumor size, diagnosis time, therapies etc. Therapies include chemotherapy, local treatment (radiotherapy, ablation, transcatheter atrial chemoembolization etc.), surgical treatment etc. The time of last antitumor treatment before signing the informed consent form must be recorded;

b. Vital signs are monitored prior to dosing, 30 ± 15 min after the start of the drip and 2 h ± 15 min after the end of the drip on the first day of dosing in cycles 1-2, respectively, and are then measured on the day of visit.

c. The scheduled date of visit is subject to the first day of dosing in the current cycle.

d. Routine blood test: in case of any hematologic toxicity above grade II, a review should be carried out within 1 week.

e. Blood biochemistry: in case of any abnormal liver function event for which the dosing regimen is adjusted downward as per the protocol, specific examination should be performed again within 1 week.

f. In case of any chest pain, palpitation or other symptom, echocardiography, myocardial zymography and troponin test should be additionally performed.

Additional information

Funding

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.