Yao Siyang, Huang Qiangsong, Zou Yan, Liu Tianqi, Yang Yongyu, Huang Tao, Zhao Yuanquan, Dong Xiaofeng
Department of Hepatobiliary, Pancreas and Spleen Surgery, The People's Hospital of Guangxi Zhuang Autonomous Region, 6 Taoyuan Road, Nanning, 530021, China.
Department of Hepatobiliary, Pancreas and Spleen Surgery, Wuming Hospital of Guangxi Medical University, 26 Yongning Road, Nanning, 530100, China.
Sci Rep. 2025 Apr 22;15(1):13960. doi: 10.1038/s41598-025-97160-7.
To validate the efficacy and safety of thymosin α-1 combined with lenvatinib plus sintilimab in the treatment of unresectable hepatocellular carcinoma. Patients with unresectable hepatocellular carcinoma treated with lenvatinib plus sintilimab at the People's Hospital of Guangxi Zhuang Autonomous Region from January 2020 to June 2022 were retrospectively analyzed. The patients were divided into an experimental group and a control group based on their therapeutic regimens: thymosin α-1 plus lenvatinib and sintilimab (experimental group), and lenvatinib plus sintilimab (control group). The primary endpoints were overall survival and progression-free survival. Tumor response was evaluated according to mRECIST criteria, and the partial response, complete response, stable disease, progressive disease, object response rate, and disease control rate of the two groups were compared. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events version 5.0. The median overall survival of all patients was 13.0 months (95% CI 10.587-15.413). The experimental group had a longer median overall survival than the control group (16 months vs. 11 months, P = 0.018). The median progression free survival of all patients was 5.0 months (95% CI 3.721-6.279). The experimental group had a longer median progression-free survival than the control group (7 months vs. 4 months, P = 0.006). The objective response rate of the experimental group was 55.8% (24/43), and of the control group's 34.7% (17/49) (P = 0.042). The disease control rate of the experimental group was 76.7% (33/43), while the control group had a rate of 59.2% (29/49) (P = 0.073). There was no significant difference in the incidence of grade 1-2 adverse events or grade 3-4 adverse events between the two groups (P > 0.05). Thymosin α-1 combined with lenvatinib plus sintilimab is an effective and safe therapeutic regimen in unresectable hepatocellular carcinoma.
验证胸腺肽α-1联合乐伐替尼及信迪利单抗治疗不可切除肝细胞癌的疗效和安全性。回顾性分析2020年1月至2022年6月在广西壮族自治区人民医院接受乐伐替尼联合信迪利单抗治疗的不可切除肝细胞癌患者。根据治疗方案将患者分为试验组和对照组：胸腺肽α-1联合乐伐替尼及信迪利单抗（试验组），以及乐伐替尼联合信迪利单抗（对照组）。主要终点为总生存期和无进展生存期。根据mRECIST标准评估肿瘤反应，比较两组的部分缓解、完全缓解、疾病稳定、疾病进展、客观缓解率和疾病控制率。使用《不良事件通用术语标准》第5.0版评估不良事件。所有患者的中位总生存期为13.0个月（95%CI 10.587-15.413）。试验组的中位总生存期长于对照组（16个月对11个月，P = 0.018）。所有患者的中位无进展生存期为5.0个月（95%CI 3.721-6.279）。试验组的中位无进展生存期长于对照组（7个月对4个月，P = 0.006）。试验组的客观缓解率为55.8%（24/43），对照组为34.7%（17/49）（P = 0.042）。试验组的疾病控制率为76.7%（33/43），而对照组为59.2%（29/49）（P = 0.073）。两组1-2级不良事件或3-4级不良事件的发生率无显著差异（P>0.05）。胸腺肽α-1联合乐伐替尼及信迪利单抗是治疗不可切除肝细胞癌的一种有效且安全的治疗方案。
