Radiofrequency Ablation in Combination With Lenvatinib and Sintilimab
Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
Lenvatinib is an oral multi-target receptor tyrosine kinase inhibitor (TKI) inhibitor that
mainly inhibits the Endothelial growth factor receptor (VEGFR) VEGFR-1,2,3; Fibroblast growth
factor receptor, FGFR) FGFR-1,2,3,4; Platelet-derived growth factor receptor (PDGFR) PDGFRα;
The kinases RET and KIT, thereby inhibiting tumor cell proliferation, inducing apoptosis, and
playing an anti-angiogenic role, have been approved by the FDA and CFDA as first-line
treatment for patients with advanced liver cancer. lenvatinib showed longer disease
progression than sorafenib (8.9 months vs. sorafenib. 3.7 months), longer progression-free
survival (7.4 months vs. 3.7 months), and higher disease control rates (24.1% vs. 9.2%).
Therefore, lenvatinib has obvious advantages in HCC treatment because of its strong
anti-angiogenic and anti-tumor growth effects.
Cindilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to
PD-1 molecules on the surface of T cells, thereby blocking the programmed death receptor-1
(PD-1)/programmed death receptor-1 ligand (PD-L1) pathway induced by tumor immune tolerance,
and reactivating the antitumor activity of lymphocytes.
In summary, recurrence after radical treatment of liver cancer is an urgent clinical problem.
Recurrent HCC treatment represented by resection, ablation and TACE is difficult to achieve
more satisfactory efficacy. As a local treatment for liver cancer, RFA has the risk of
incomplete ablation and insufficient ablation margin, and because RFA cannot resolve
micrometastases, tumor growth, invasion and metastasis occur. Therefore, RFA combined with
lenvatinib and immune checkpoint inhibitors have theoretical complementary advantages, and
this study intends to compare the clinical efficacy and safety of radical resection/ablation
RFA combined with lenvatinib + sindilimab in the treatment of patients with early recurrent
liver cancer compared with RFA alone.