Targeted Therapies in Trial for Non-Resectable Gallbladder Cancer
Ali A Nasrallah1, Hussein H Khachfe2,3, Hamza A Salhab1,4
1Faculty of Medicine, American University of Beirut, Beirut, 1107 2020, Lebanon.
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.
Insights
Clinical trials for gallbladder cancer (GBC) are limited, with few publications. Gemcitabine-based therapies show promise for progression-free survival in non-resectable GBC.
Area of Science:
- Oncology
- Clinical Trials Research
- Biliary Tract Malignancies
Background:
- Gallbladder cancer (GBC) is the most common biliary tract malignancy.
- Median survival for GBC is approximately 6 months.
- Limited treatment options exist for non-resectable GBC.
Purpose of the Study:
- To explore clinical trials for non-resectable GBC.
- To identify shortcomings in GBC treatment development.
- To suggest areas for improvement in GBC research.
Main Methods:
- A comprehensive search of ClinicalTrials.gov was conducted for therapeutic and interventional trials in non-resectable GBC.
- Trial characteristics including duration, phase, and sample size were analyzed.
- Publication output from trials was assessed.
Main Results:
- Sixty-two trials met the criteria, with an average duration of 5 years.
- Most trials (88%) were in early phases (I-II) and primarily conducted in North America.
- Only 4 publications resulted from the trials; gemcitabine-based regimens showed improved progression-free survival.
Conclusions:
- The study highlights a low number of trials, limited geographic diversity, and a scarcity of publications for non-resectable GBC.
- Effective therapies for GBC require adequate management and further research.
- Gemcitabine combinations offer a potential avenue for improved outcomes.
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