Lenvatinib, sintilimab plus transarterial chemoembolization for advanced stage hepatocellular carcinoma: A phase II study.
Liver Int
; 44(4): 920-930, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-38291865
ABSTRACT
BACKGROUND & AIMS:
Our retrospective study has suggested encouraging outcomes of lenvatinib combined with PD-1 inhibitor and transarterial chemoembolization (TACE) on advanced hepatocellular carcinoma (HCC). This phase II trial was conducted to prospectively investigate the efficacy and safety of lenvatinib, sintilimab (a PD-1 inhibitor) plus TACE (Len-Sin-TACE) in patients with advanced stage HCC.METHODS:
This was a single-arm phase II trial. Patients with BCLC stage C HCC were recruited. They received lenvatinib (bodyweight ≥60 kg, 12 mg; bodyweight <60 kg, 8 mg) orally once daily, sintilimab (200 mg) intravenously once every 3 weeks, and on demand TACE. The primary endpoint was progression-free survival (PFS) per mRECIST.RESULTS:
Thirty patients were enrolled. The primary endpoint was met with a median PFS of 8.0 (95% confidence interval [CI] 6.1-9.8) months per mRECIST, which was the same as that per RECIST 1.1. The objective response rate was 60.0% per mRECIST and 30.0% per RECIST 1.1. The disease control rate was 86.7% per mRECIST/RECIST 1.1. The median duration of response was 7.4 (95% CI 6.6-8.2) months per mRECIST (n = 18) and 4.3 (95% CI 4.0-4.6) months per RECIST 1.1 (n = 9). The median overall survival was 18.4 (95% CI 14.5-22.3) months. Treatment-related adverse events (TRAEs) occurred in 28 patients (93.3%) and grade 3 TRAEs were observed in 12 patients (40.0%). There were no grade 4/5 TRAEs.CONCLUSIONS:
Len-Sin-TACE showed promising antitumour activities with a manageable safety profile in patients with advanced stage HCC. The preliminary results need to be further evaluated with phase III randomized trials.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Compuestos de Fenilurea
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Quinolinas
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Quimioembolización Terapéutica
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Carcinoma Hepatocelular
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Anticuerpos Monoclonales Humanizados
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Neoplasias Hepáticas
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Humans
Idioma:
En
Revista:
Liver Int
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
China