drugset / Trial / NCT07304388
HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC
RandomizedParallel-groupOpen-labelTreatment
Summary
Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC. Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.
Timeline
- Start
- 2023-02-10
- Primary completion
- 2025-04-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1 g | Intravenous |
| Comparator | Lenvatinib | Small molecule | 8 mg | Oral |
| Comparator | Lenvatinib | Small molecule | 12 mg | Oral |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Comparator | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |