Chen Qi, Ge Nai-Jian, Li Yu-Liang, Huang Ming, Li Wen-Hui, Lu Dong, Wei Ning, Lv Peng-Hua, Tu Jian-Fei, He Cheng-Jian, Wang Wu-Jie, Ding Rong, Peng Bo, Wang Xue-Jun, Wang Fu-An, Zhu Guang-Yu, Wang Yong, Chen Li, Min Jie, Guo Jin-He, Teng Gao-Jun, Lu Jian
Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Southeast University, Nanjing.
Int J Surg. 2025 Jan 1;111(1):706-717. doi: 10.1097/JS9.0000000000002089.
Self-expandable metallic stents (SEMSs) have been recommended for patients with unresectable malignant biliary obstruction, while radiation-emitting metallic stents (REMSs) loaded with 125 I seeds have recently been approved to provide longer patency and overall survival in malignant biliary tract obstruction. This trial is to evaluate the efficacy and safety of REMS plus hepatic arterial infusion chemotherapy (REMS-HAIC) versus SEMS plus HAIC (SEMS-HAIC) for unresectable perihilar cholangiocarcinoma (pCCA).
This multicenter randomized controlled trial recruited patients with unresectable Bismuth type III or IV pCCA between March 2021 and January 2023. Patients were randomly assigned (1:1 ratio) to receive either REMS-HAIC or SEMS-HAIC using permuted block randomization, with a block size of six. The primary endpoint was overall survival (OS). The secondary endpoints were time to symptomatic progression (TTSP), stent patency, relief of jaundice, quality of life, and safety.
A total of 126 patients were included in the intent-to-treat population, with 63 in each group. The median OS was 10.2 months versus 6.7 months ( P =0.002). The median TTSP was 8.6 months versus 5.4 months ( P =0.003). The median stent patency was longer in the REMS-HAIC group than in the SEMS-HAIC group ( P =0.001). The REMS-HAIC group showed better improvement in physical functioning scale ( P <0.05) and fatigue symptoms ( P <0.05) when compared to the SEMS-HAIC group. No significant differences were observed in relief of jaundice (85.7% vs. 84.1%; P =0.803) or the incidence of grade 3 or 4 adverse events (9.8% vs. 11.9%; P =0.721).
REMS plus HAIC showed better OS, TTSP, and stent patency compared with SEMS plus HAIC in patients with unresectable Bismuth type III or IV pCCA with an acceptable safety profile.
自膨式金属支架（SEMS）已被推荐用于不可切除的恶性胆管梗阻患者，而装载125I粒子的放射性金属支架（REMS）最近已获批准，可在恶性胆管梗阻中提供更长的通畅时间和总生存期。本试验旨在评估REMS联合肝动脉灌注化疗（REMS-HAIC）与SEMS联合HAIC（SEMS-HAIC）治疗不可切除的肝门部胆管癌（pCCA）的疗效和安全性。
本多中心随机对照试验在2021年3月至2023年1月期间招募了不可切除的Bismuth III型或IV型pCCA患者。采用置换区组随机化方法将患者按1:1比例随机分配接受REMS-HAIC或SEMS-HAIC治疗，区组大小为6。主要终点为总生存期（OS）。次要终点为出现症状进展的时间（TTSP）、支架通畅性、黄疸缓解情况、生活质量和安全性。
意向性分析人群共纳入126例患者，每组63例。中位OS为10.2个月对6.7个月（P = 0.002）。中位TTSP为8.6个月对5.4个月（P = 0.003）。REMS-HAIC组的中位支架通畅时间长于SEMS-HAIC组（P = 0.001）。与SEMS-HAIC组相比，REMS-HAIC组在身体功能量表（P < 0.05）和疲劳症状（P < 0.05）方面改善更明显。黄疸缓解情况（85.7%对84.1%；P = 0.803）或3级或4级不良事件发生率（9.8%对11.9%；P = 0.721）未观察到显著差异。
在不可切除的Bismuth III型或IV型pCCA患者中，与SEMS联合HAIC相比，REMS联合HAIC显示出更好的OS、TTSP和支架通畅性，且安全性可接受。
