Sijia Gu1,2,3,6, Qiyu Luo1,2,3,6, Yalei Zhang1,4, Ling Qian1,4, Kun Chen1,4, Fei Liang 5,
Yudi Hu1,2,3, Runye Zhou1,2,3, Yating Wang1,2,3, Jingjing Liu1,2,3, Zhouyu Ning4,
Litao Xu4, Zhiqiang Meng4, Ye Li1,2,3 & Peng Wang 1,2,3
[Abstract] Treatment options for advanced or metastatic intrahepatic cholangiocarcinoma (ICC) are limited. In this single-arm, phase 2 trial(CASTLE-01, NCT05010668), 28 participants with advanced or metastatic ICC who have progressed after chemotherapy were treated with cryoablation,
followed by anti-PD1 sintilimab (200 mg every 3 weeks) plus Lenvatinib (8–12 mg per day) 2 weeks later. The objective response rate assessed by Response Evaluation Criteria in Solid Tumors version 1.1 was 75.0% (95% confidence interval (CI): 59–91%), meeting the prespecified primary endpoint. Secondary endpoints of disease control rate, median progression-free survival and overall survival were respectively 100% (95% CI: 100–100%), 16.8 months (95% CI: 11.5–not reached (NR)) and 25.4 months (95% CI: 13.3–NR).
Objective Response Rate (ORR): 75.0%
Disease Control Rate (DCR): 100%
Median Progression-Free Survival (PFS): 16.8 months
Median Overall Survival (OS): 25.4 months
These findings also support the notion that cryoablation may trigger abscopal antitumor immunity in ICC when combined with Lenvatinib and PD1 blockade.
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