Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01): a Multicenter, Randomized, Phase 2 Study
Fudan University
92 participants
Mar 18, 2025
INTERVENTIONAL
Conditions
Summary
This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus Tislelizumab compared with FOLFOX in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Tislelizumab will be administered by IV, 200 mg on day 1 of each 21 day cycle.
Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily
Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone. Lenvatinib plus Tislelizumab will be administered 1-3 days after cryoablation.
FOLFOX chemotherapy was administered intravenously every 2 weeks for a maximum of 12 cycles (oxaliplatin 85 mg/m², leucovorin, 400 mg/m2, fluorouracil 400 mg/m² \[bolus\], and fluorouracil 2400 mg/m² as a 46-h continuous intravenous infusion
Locations(1)
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NCT06860477