Efficacy and Safety of Capecitabine, Irinotecan, Gemcitabine, and Bevacizumab as Second-Line Treatment in Advanced Biliary Tract Cancer: A Phase II Study

<b><i>Objective:</i></b> Since 2010, gemcitabine and cisplatin have been considered standard first-line treatment in patients with advanced biliary tract cancer. Many centers have replaced cisplatin with oxaliplatin, which seems to obtain similar results. While first-line treatment has been well established, there are no phase III trials supporting second-line treatment, and the phase II trials with chemotherapy do not show any clear benefit. In this study, we investigated the effect of adding bevacizumab to chemotherapy in second-line treatment. <b><i>Methods:</i></b> From November 2013 to January 2016, 50 patients with advanced biliary tract cancer were enrolled in this prospective phase II trial. All patients had received a gemcitabine-platinum combination as first-line treatment. The patients received capecitabine, irinotecan, gemcitabine, and bevacizumab in a 2-week schedule as second-line treatment. <b><i>Results:</i></b> The combination was well tolerated with a median progression-free survival of 3.6 months, a median overall survival of 6.4 months, and a response rate of 6%. <b><i>Conclusion:</i></b> The combination of capecitabine, irinotecan, gemcitabine, and bevacizumab as a second-line treatment for advanced biliary tract cancer is well tolerated but with a modest, if any, benefit.