用Ropeginterferon Alfa-2b和抗编程细胞死亡1抗体进行序列治疗,以抑制B型肝炎相关肝细胞癌的复发:从动物模型到I期临床结果
Albert Qin1, Chang-Ru Wu2, Ming-Chih Ho3
1Medical Research & Clinical Operations, PharmaEssentia Corporation, Taipei 115, Taiwan.
International journal of molecular sciences
|January 11, 2024
概括
结合干扰素-α和PD-1阻断的序列疗法在预防手术后肝细胞癌 (HCC) 复发方面表现有前途. 这种方法在小鼠中显示出显著的乙型肝炎病毒 (HBV) 抑制和人类患者的早期安全性.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 免疫治疗是一种免疫疗法.
- 病毒学 病毒学
背景情况:
- 肝细胞癌 (HCC) 在手术切除后经常复发,目前没有批准的辅助疗法可用.
- 乙型肝炎病毒 (HBV) 是HCC的主要原因,其清除对于预防复发至关重要.
研究的目的:
- 在HBV相关的HCC的动物模型中,评估使用干扰素α和PD-1阻断的顺序组合治疗的疗效.
- 评估连续使用罗佩干扰素α-2b和尼沃卢马布的安全性,耐受性和初步疗效,用于接受治疗手术的HBV相关HCC患者.
主要方法:
- 一项动物研究使用重组小鼠干扰素-α (rmIFN-α) 和抗小鼠PD1抗体来评估HBV抑制.
- 一个I期临床试验,涉及11名患者,在手术后分别接受rope-interferon alfa-2b和nivolumab治疗,治疗HBV相关的HCC.
主要成果:
- 连续的rmIFN-α和抗PD1治疗显示,与单一治疗相比,小鼠的HBV抑制显著增加.
- 在I期试验中,两名患者经历了HBV表面抗原显著减少或清除.
- 确定了最大耐受剂量,治疗一般耐受良好,迄今为止没有观察到HCC复发.
结论:
- 使用干扰素α和PD-1阻断的顺序组合疗法是一种潜在的预防策略,可以预防手术后与HBV相关的HCC复发.
- 需要进一步的临床开发,以确定这种顺序治疗作为高风险HCC患者的辅助治疗.
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