Observation on the efficacy and safety of atezolizumab plus donafenib in the treatment of advanced unresectable hepatocellular carcinoma
- VernacularTitle:阿替利珠单抗联合多纳非尼治疗晚期不可切除肝细胞癌的疗效与安全性观察
- Author:
Chen XU
1
;
Zhikai YANG
1
;
Jingpo ZHANG
1
Author Information
1. Dept. of Hepatobiliary and Pancreatic Surgery，The First Hospital of Hebei Medical University，Shijiazhuang 050031，China
- Publication Type:Journal Article
- Keywords:
advanced unresectable hepatocellular carcinoma;
Atezolizumab;
donafenib;
bevacizumab;
interventional therapy;
Efficacy
- From:
China Pharmacy
2026;37(19):2550-2555
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To investigate the efficacy and safety of atezolizumab plus donafenib in patients with advanced unresectable hepatocellular carcinoma （uHCC）.METHODS Patients with uHCC treated at the Dept. of Hepatobiliary and Pancreatic Surgery， The First Hospital of Hebei Medical University， from May 1， 2023 to April 30， 2025 were selected as study subjects for a retrospective study. All patients received interventional therapy with transcatheter arterial chemoembolization （TACE） and/or hepatic arterial infusion chemotherapy （HAIC）. On this basis， patients were divided according to the systemic treatment regimen into a control group （atezolizumab plus bevacizumab， n ＝56） and an observation group （atezolizumab plus donafenib， n ＝49）. Short-term efficacy at 3 months after treatment and long-term efficacy were compared between the two groups. Subgroup analyses were further performed with sex， age， hepatitis B， liver cirrhosis， Child-Pugh class， Barcelona Clinic Liver Cancer （BCLC） stage， Eastern Cooperative Oncology Group Performance Status （ECOG-PS） score， tumor number， maximum tumor diameter， portal vein tumor thrombus， and interventional treatment modality as subgroup variables， with interaction tests conducted between subgroup variables and treatment group. Adverse reactions during treatment were compared between the two groups.RESULTS At 3 months after treatment， the disease control rate was significantly higher in the observation group than in the control group （ P ＜0.05）， whereas the difference in objective response rate between the two groups was not statistically significant （ P ＞0.05）. The median progression-free survival was 7.53 months [95% confidence interval （CI）： 6.32-8.53 months] in the control group and 8.06 months （95%CI： 7.33-9.70 months） in the observation group， with no statistically significant difference between the two groups （ P ＞0.05）. The median overall survival was 13.56 months （95%CI： 11.23-15.77 months） in the control group and 14.92 months （95%CI： 12.93-17.11 months） in the observation group， and overall survival was significantly longer in the observation group than in the control group （ P ＜0.05）. Subgroup analysis showed that among patients with Child-Pugh class A， BCLC stage B， or without portal vein tumor thrombus， the risk of death was lower in the observation group than in the control group， with hazard ratios of 0.46， 0.49 and 0.44， respectively， and interaction P values of 0.035， 0.008 and 0.013， respectively. Adverse reactions in both groups were mainly grade 1-2， and there were no statistically significant differences in the incidence of individual adverse reactions between the two groups （ P ＞0.05）.CONCLUSIONS In patients with advanced uHCC receiving interventional therapy， the atezolizumab plus donafenib regimen was associated with a higher disease control rate and longer overall survival， and this association was mainly observed in patients with Child-Pugh class A， BCLC stage B， or without portal vein tumor thrombus.
