drugset / Trial / NCT05621499
HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma
Timeline
- Start
- 2022-11
- Primary completion
- 2023-11
- Completion
- 2025-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg/kg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg/kg | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin 85 mg/m2, LV 400 mg/ m2, 5-FU 400 mg/m2 bolus and then 2400 mg/m2 as 46h continuous infusion，Q3W，a total of 2 cycles | Unknown | 400 mg/m2 | — |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |