Faculty of Medicine, American University of Beirut, Beirut, 1107 2020, Lebanon.
Neuroscience Research Center, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon.
J Gastrointest Cancer. 2021 Jun;52(2):515-522. doi: 10.1007/s12029-020-00411-1.
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.
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.
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.
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.
胆囊癌（GBC）是胆道最常见的恶性肿瘤。该病的中位生存期约为 6 个月。本研究探讨了与不可切除 GBC 相关的临床试验，确定了导致新治疗方法发展不足的缺陷，并为可能的改进领域提供了启示。
2019 年 4 月 20 日，作者在 ClinicalTrials.gov 上对所有涉及不可切除 GBC 的治疗和介入性临床试验进行了检索，对日期和地点没有任何限制。收集并分析了试验特征，如持续时间、阶段、样本量以及是否发表了出版物。
62 项试验符合我们的选择标准。试验的平均持续时间为 5 年。试验在 8 个不同的国家进行：大多数在北美（美国和加拿大）。约 88%的试验处于早期阶段（I、I/II 和 II），85%的试验已经完成。从我们研究中的所有试验中仅产生了 4 篇相关出版物。吉西他滨是最常用的药物。吉西他滨单独或与卡培他滨或顺铂联合使用显示出显著增加的中位无进展生存期。
这项研究显示，不可切除 GBC 的试验数量较少，地理多样性缺乏，出版物稀缺。充分管理对于为这种疾病找到有效的治疗方法非常重要。
