Zhang Ning, Zhang Yongfa, Yu Bingran, Wang Yixiu, Wang Miao, Pan Qi, Mao Anrong, Zhu Weiping, Zhao Yiming, Zhang Ti, Wang Lu
Department of Hepatic Surgery, Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai 201102, China.
Department of Pediatric Surgery, Children's Hospital of Fudan University, and Shanghai Key Laboratory of Birth Defects, Shanghai 201102, China.
Innovation (Camb). 2025 Apr 11;6(7):100910. doi: 10.1016/j.xinn.2025.100910. eCollection 2025 Jul 7.
In this single-arm, phase 2 study, we explored the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with anlotinib and TQB2450 (an anti-PD-L1 antibody) as a postoperative adjuvant treatment in patients at high risk of hepatocellular carcinoma (HCC) recurrence. Patients with high-risk recurrence of HCC were treated with HAIC, anlotinib (4 or 8 cycles), and TQB2450 after curative surgery. The primary endpoint was disease-free survival (DFS), and the secondary endpoints included overall survival (OS) and safety. 77 patients who met the inclusion criteria were enrolled: 38 in the 4-cycle cohort and 39 in the 8-cycle cohort. As of the data cutoff on June 24, 2024, the median follow-up period was 21.19 months (95% confidence interval [CI], 20.49-21.89). The median DFS and OS of all patients were not reached. 1-year and 2-year DFS rates were 84.4% and 65.8%, respectively, while 1-year and 2-year OS rates were 96.1% and 89.8%, respectively. No significant differences in DFS and OS were observed in patients treated with 4 or 8 cycles of anlotinib. The incidence of grade 3/4 adverse events (AEs) was 28.6%. Postoperative adjuvant HAIC combined with anlotinib and TQB2450 demonstrated encouraging clinical benefits in reducing recurrence with manageable toxicities in patients at high risk of HCC recurrence. 4-cycle anlotinib combined with HAIC and TQB2450 is recommended as an adjuvant treatment for further investigation.
在这项单臂2期研究中，我们探讨了肝动脉灌注化疗（HAIC）联合安罗替尼和TQB2450（一种抗PD-L1抗体）作为肝细胞癌（HCC）复发高危患者术后辅助治疗的疗效和安全性。HCC复发高危患者在根治性手术后接受HAIC、安罗替尼（4或8个周期）和TQB2450治疗。主要终点为无病生存期（DFS），次要终点包括总生存期（OS）和安全性。77例符合纳入标准的患者入组：4周期队列38例，8周期队列39例。截至2024年6月24日的数据截止日期，中位随访期为21.19个月（95%置信区间[CI]，20.49-21.89）。所有患者的中位DFS和OS均未达到。1年和2年DFS率分别为84.4%和65.8%，而1年和2年OS率分别为96.1%和89.8%。接受4或8个周期安罗替尼治疗的患者在DFS和OS方面未观察到显著差异。3/4级不良事件（AE）的发生率为28.6%。术后辅助HAIC联合安罗替尼和TQB2450在降低HCC复发高危患者的复发率方面显示出令人鼓舞的临床益处，且毒性可控。推荐4周期安罗替尼联合HAIC和TQB2450作为辅助治疗进行进一步研究。
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