Ali A Nasrallah1, Hussein H Khachfe2,3, Hamza A Salhab1,4, Mohamad Y Fares1,4, Jawad Fares5. 1. Faculty of Medicine, American University of Beirut, Beirut, 1107 2020, Lebanon. 2. Faculty of Medicine, American University of Beirut, Beirut, 1107 2020, Lebanon. hhk15@mail.aub.edu. 3. Neuroscience Research Center, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon. hhk15@mail.aub.edu. 4. Neuroscience Research Center, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon. 5. Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, 60611, USA.
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.
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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