Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation
Summary
1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma. 2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate). 3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.
Timeline
- Start
- 2023-09
- Primary completion
- 2026-06
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Other |
| Subject | Donafenib | Small molecule | 200 mg | Oral |
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Regorafenib | Small molecule | — | — |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |