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Targeted Therapies in Trial for Non-Resectable Gallbladder Cancer

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Abstract

Purpose

Gallbladder cancer (GBC) is the most common malignancy of the biliary tract. The median survival of the disease is around 6 months. In this study, we explore clinical trials related to non-resectable GBC, determine the shortcomings leading to the lack of development of new treatment, and shed light on possible areas of improvement.

Methods

On April 20, 2019 the authors completed a search on ClinicalTrials.gov for all therapeutic and interventional clinical trials involving non-resectable GBC, without any limits on date or location. Trial characteristics such as duration, phase, sample size, and whether a publication was produced were collected and analyzed.

Results

Sixty-two trials met our selection criteria. The average duration of trials was 5 years. Trials were conducted in 8 different countries: most of them in North America (USA and Canada). About 88% of trials were in early phases (I, I/II, and II) and 85% of trials were completed. Only 4 relevant publications were produced from all the trials in our study. Gemcitabine was the most common drug used. Use of gemcitabine alone or in combination with either capecitabine or cisplatin showed significant increase mean progression-free survival.

Conclusion

This study revealed a low number of trials, lack of geographic diversity, and scarcity of publications concerning non-resectable GBC. Adequate management of is of great importance to reach effective therapies for this disease.

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Author information

Authors and Affiliations

  1. Faculty of Medicine, American University of Beirut, Beirut, 1107 2020, Lebanon

    Ali A. Nasrallah, Hussein H. Khachfe, Hamza A. Salhab & Mohamad Y. Fares

  2. Neuroscience Research Center, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon

    Hussein H. Khachfe, Hamza A. Salhab & Mohamad Y. Fares

  3. Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, 60611, USA

    Jawad Fares

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  1. Ali A. Nasrallah
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  2. Hussein H. Khachfe
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  3. Hamza A. Salhab
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  4. Mohamad Y. Fares
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Contributions

A.A.N and H.H.K were responsible for the concept and design of the study; A.A.N, H.H.K, and H.A.S. data acquisition; H.H.K and M.Y.F. statistical analysis; H.H.K, H.A.S, M.Y.F, and JF interpreted the results; A.A.N, H.H.K, and JF analyzed the data and drafted the manuscript. All authors critically revised the manuscript, approved the final version to be published, and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Hussein H. Khachfe.

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The authors declare that they have no conflicts of interest.

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Nasrallah, A.A., Khachfe, H.H., Salhab, H.A. et al. Targeted Therapies in Trial for Non-Resectable Gallbladder Cancer. J Gastrointest Canc 52, 515–522 (2021). https://doi.org/10.1007/s12029-020-00411-1

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