This disclosure relates to dosage regimens for targeted TGF-β inhibition with a bi-functional fusion protein for use in a method of treating biliary tract cancer or inhibiting biliary tract tumor growth in treatment naïve patients, or patients with locally advanced or metastatic BTC who have failed or are intolerant to first-line systemic chemotherapy.本發明係關於用雙功能融合蛋白標靶TGF-β抑制之給藥方案,用於治療膽道癌或抑制膽道腫瘤生長於初始(naïve)治療患者或一線全身化學療法失敗或不耐受的局部晚期或轉移性BTC之患者的方法中。