drugset / Trial / NCT06860477
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-18
- Primary completion
- 2027-03-15
- Completion
- 2028-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |