At a glance
ClinicalIndex Comparison Record- ✓Unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma
- ✓Failed 1 line of systemic therapy for advanced cholangiocarcinoma due to disease progression or toxicity
- ✓At least one measurable site of disease by RECIST criteria
- ✓Age ≥18 years
- ✕History of cardiac disease or clinically significant gastrointestinal bleeding within 4 weeks
- ✕Thrombotic or embolic events within 6 months prior to first dose
- ✕Prior treatment with cryoablation
- ✕Prior treatment with Lenvatinib or other targeted therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01): a Multicenter, Randomized, Phase 2 Study
In Brief
A Phase 2 clinical trial evaluating Tislelizumab, Lenvatinib, and 2 other interventions for Intrahepatic Cholangiocellular Carcinoma. Currently recruiting, targeting 92 participants across 1 site.
Detailed 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.
Study Details
Timeline
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