Single-center phase 2 trial of cryoablation plus sintilimab and lenvatinib for advanced or metastatic intrahepatic cholangiocarcinoma

Treatment options for advanced or metastatic intrahepatic cholangiocarcinoma (ICC) are limited. In the phase 2 CASTLE-01 trial at Shanghai Fudan University (China), 28 patients with advanced or metastatic ICC who progressed after chemotherapy underwent cryoablation, two weeks later followed by sintilimab and lenvatinib. The objective response rate was 75.0% (95% CI 59-91), meeting the primary endpoint. Disease control rate was 100% (95% CI 100-100), median progression-free survival was 16.8 months (11.5-NR), and median overall survival was 25.4 months (13.3-NR). Treatment was well tolerated.