P-19 A multicentred phase II clinical trial on yttrium 90-resin microspheres followed by gemcitabine-cisplatin for treatment of locally advanced intra-hepatic cholangiocarcinoma

摘要: BackgroundYttrium 90-resin microspheres (Y90-RE) has been reported to be effective in treating intra-hepatic cholangiocarcinoma (ICC). This phase II, investigator-initiated, clinical trial aims to study the efficacy and feasibility of administering Y90-RE followed by standard gemcitabine-cisplatin (GC) chemotherapy in unresectable ICC (NCT02167711).MethodsPatients with histologically proven, treatment-naïve, inoperable ICC (abdominal nodal disease allowed), ECOG 0-1 performance status were eligible. Exclusion criteria included complete thrombosis of main portal vein; and tumour volume> 50% of liver. Y90-RE (target dose 120Gy) was given when assessments showed lung shunting (≤ 15%) and tumour to liver uptake ratio≥ 2. Gemcitabine 1000mg/m2 and cisplatin 25mg/m2 (D1, 8 q3w; maximum 8 cycles) was started 7 days after Y90-RE if no significant toxicities from Y90-RE were noted. The primary …