Last reviewed · How we verify
HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion
The combination of HAIC with systemic therapy can provide superior efficacy compared to systemic therapy alone or local therapy alone for patients with advanced HCC complicated by vascular invasion, regardless of whether they have extrahepatic metastasis, with overall manageable safety. Currently, guidelines have recommended HAIC for HCC patients with unresectable primary tumors, PVTT type I/II/III/IV, and Child-Pugh A liver function, and recognize that its combination with sorafenib for patients with PVTT has superior efficacy compared to sorafenib monotherapy. However, more evidence is still needed regarding the efficacy of HAIC combined with lenvatinib and PD-1 inhibitors for patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion. This study aims to further validate the efficacy and safety of lenvatinib and PD-1 inhibitors ± HAIC for HCC patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion through larger sample size multicenter real-world data, with the goal of providing new evidence-based guidance for HCC treatment in clinical practice. This study is to evaluate the efficacy and safety of HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib combined with PD-1 inhibitors in the first-line treatment of advanced hepatocellular carcinoma with major vascular or biliary invasion
Details
| Lead sponsor | Peking University |
|---|---|
| Status | NOT_YET_RECRUITING |
| Enrolment | 150 |
| Start date | Sun Mar 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- HAIC
- Lenvatinib
- PD-1 Inhibitors
- Lenvatinib 1
- PD-1 inhibitors 1
Countries
China