We are proud to share that Fudan Zhongshan Hospital, using Hygea’s Co-Ablation system, has published a landmark clinical study in Nature Cancer (2025), titled “Cryoablation plus sintilimab and lenvatinib in advanced or metastatic intrahepatic cholangiocarcinoma: a phase 2 trial.” Read the paper: Nature Cancer (2025)
In this CASTLE-01 Phase II trial (NCT05010668), 28 patients with advanced or metastatic intrahepatic cholangiocarcinoma received cryoablation followed by immunotherapy (sintilimab and lenvatinib) The results were exceptional:
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
Post-treatment analyses revealed that cryoablation enhanced tumor immunogenicity and dendritic cell activation, leading to continuous replenishment of intratumoral CD8⁺PD1ʰⁱ effector T cells and transforming “cold” tumors into “hot” ones.
These findings provide compelling evidence that cryoablation can synergize with immunotherapy to trigger systemic (abscopal) antitumor responses, opening new possibilities for treating advanced cancers.
Reference:
Gu S. et al. Nature Cancer (2025). DOI: 10.1038/s43018-025-01058-2
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