OncoMatch/Clinical Trials/NCT05803928
Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies
Is NCT05803928 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies lenvatinib + anti-PD-1 antibodies for hepatocellular carcinoma.
Treatment: lenvatinib + anti-PD-1 antibodies — 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. The main ablative techniques includes radiofrequency ablation, microwave ablation and cryoablation.As a local treatment for liver cancer, ablation has the risk of incomplete ablation and insufficient ablation margin, and because RFA cannot resolve micrometastases, tumor growth, invasion and metastasis occur. Therefore, ablation combined with lenvatinib and immune checkpoint inhibitors have theoretical complementary advantages, and this study intends to compare the clinical efficacy and safety of ablation combined with lenvatinib plus anti-PD-1 antibodies in the treatment of patients with early recurrent liver cancer compared with ablation alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radical resection or ablation
2 months after radical resection or ablation, imaging examination (MRI, CT plain enhanced) showed no tumor lesions, HCC recurred within 3 years after surgery
Cannot have received: radiotherapy
previous radiotherapy
Cannot have received: hormone therapy
previous...hormone therapy
Cannot have received: molecular targeted therapy
previous...molecular targeted therapy
Lab requirements
Blood counts
HGB≥9.0g/dl, neutrophils ≥1,500/mm3, PLT≥50x10^9/L, serum ALB≥28g/L
Kidney function
Bun, Cr< 1.5x ULN
Liver function
Child-Pugh liver function grades: A, B; TBIL<2mg/dL, ALT, AST< 5x ULN
Cardiac function
no heart disease, coronary heart disease, cardiac function level 1-2
Adequate organ function: ① no need for growth factors and blood components within 2 weeks prior to enrollment; (2) Cardiac function: no heart disease, coronary heart disease, cardiac function level 1-2; ③ In the first 7 days of enrollment, liver and kidney function was adequate and laboratory indicators were suitable (untreated) : HGB≧9.0g/dl, neutrophils ≧1,500/mm3, PLT≧50x109/L, serum ALB≧28g/L, TBIL<2mg /dL, ALT, AST< 5 times of the upper limit of normal value, Bun, Cr< 1.5 times of the upper limit of normal value, INR<1.7 or extended PT<3s
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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