Abstract
Since the survival benefit of combined gemcitabine plus cisplatin therapy (GC therapy) over gemcitabine alone has been demonstrated in randomized controlled clinical trials, the GC therapy has been recognized as a standard therapy for unresectable biliary tract cancer. On the other hand, in a randomized phase II study comparing combined gemcitabine plus S-1 chemotherapy (GS therapy) and S-1 alone, GS therapy also showed promising activity against biliary tract cancer. Based on these results, a phase III study comparing GS therapy with GC therapy is currently under investigation. No standard treatment has established in the second-line therapy or adjuvant therapy after surgery for biliary tract cancer. Phase III studies using gemcitabine or S-1 are conducted as adjuvant therapy in Japan. New molecular targeted agents are currently under investigation in a second line. Standard treatments of the second line therapy and adjuvant therapy would be established in the near future.
