A review on the latest clinical trials of gallbladder cancer

Gallbladder cancer (GC) is a relatively uncommon form of cancer; however, it accounts for nearly half of all biliary tract cancers are extremely deadly malignancies, with a 17.6% survival rate over a 5-year period. The prognosis for GC is typically unfavorable due to its aggressive tumor characteristics, late detection, complex anatomical location, and advanced stage when diagnosed. However, if detected early, surgical removal followed by additional treatments can offer a potential cure. Despite radical removal for GC, the incidence of tumor recurrence after surgery and five-year rate of survival are still unacceptable high. In cases of locally advanced and metastatic disease, therapeutic options primarily involve palliative chemotherapy. Therefore, it is crucial to prioritize the development of additional treatment alternatives for patients with GC. This includes adjuvant therapy before and after surgery, as well as first- and second-line therapies for managing disease advancement throughout the entire treatment process. Due to the challenging nature of treating this malignancy, our focus is on reviewing the latest clinical trials in this field and comparing the efficacy of different treatments, as well as their respective side effects. Method: We searched for related clinical trials published since 2023 using Google Scholar and PubMed. Any articles that met our criteria were included in this study. Result: In overall, the disease control rate (DCR) for combination therapy of gemcitabine and cisplatin is 82%, whereas for capecitabine with chemoradiation, it is 62%. In biliary tract cancer, the DCR for the combination of gemcitabine and cisplatin was 66.7%. In individuals with GC who did not respond to gemcitabine-based chemotherapy, salvage chemotherapy combining pemetrexed and erlotinib exhibited showed excellent tolerability and achieved a DCR of 55%. Nucleoside FF-10502-01 demonstrated excellent tolerability, with side effects being easily managed. Furthermore, with FF-10502-01, long-lasting partial responses and disease stabilizations were observed in patients with advanced biliary cancer who had previously received gemcitabine treatment. A clinical trial revealed that adding nanoliposomal irinotecan to fluorouracil plus leucovorin failed to enhance progression-free survival or overall survival. Moreover, it resulted in increased toxicity when compared to fluorouracil plus leucovorin alone. In HER2-positive biliary tract cancer, the use of second- or third-line trastuzumab biosimilar alongside oxaliplatin, folinic acid, and fluorouracil has demonstrated highly encouraging efficacy with manageable side effects. This treatment approach led to an impressive DCR of 79.4%. Conclusion: Clinical trials for the treatment of gallbladder cancer have demonstrated significant progress. These studies are specifically dedicated to exploring targeted and combination therapy approaches in order to minimize side effects and enhance survival rates among patients. The existing evidence is limited, mainly because of the small sample size of the studies. Furthermore, long-term evaluations are needed to determine the most effective treatment options.

A review on the latest clinical trials of gallbladder cancer Keywords:

Gallbladder cancer , Clinical trial , Malignancy