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A Randomized, Controlled, Open-label, Multi-center Clinical Trial of Multi-kinase Inhibitor Combined With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma and High-risk Recurrence Factors After Liver Transplantation
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.
Details
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 88 |
| Start date | 2023-09 |
| Completion | 2027-01 |
Conditions
- Liver Transplant; Complications
- Hepatocarcinoma
- Recurrent Osteosarcoma
- High-Risk Cancer
Interventions
- multi-kinase inhibitors in combination with bevacizumab
Primary outcomes
- EFFICACY: One-year recurrence-free survival rate (1-year RFS rate) — Baseline up to 12 months
One-year recurrence-free survival rate (1-year RFS rate): The one-year recurrence-free survival rate represents the proportion of patients, within a specified study population, who remain free from disease recurrence for at least one year following a designated treatment or intervention.
Countries
China