drugset / Trial / NCT06201065
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.
Timeline
- Start
- 2023-12-26
- Primary completion
- 2025-07-26
- Completion
- 2026-12-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Lenvatinib | Small molecule | 8 mg | Oral |
| Background | Lenvatinib | Small molecule | 12 mg | Oral |
| Background | Leucovorin | Small molecule | — | Other |
| Background | Oxaliplatin | Small molecule | — | Other |
| Background | fluorouracil | Small molecule | — | Other |