卡瑞利珠单抗联合沙利度胺治疗晚期肝细胞癌的疗效及安全性

Safety and efficacy of camrelizumab combined with thalidomide for advanced hepatocellular carcinoma

目的:评估卡瑞利珠单抗联合沙利度胺在晚期肝细胞癌患者中的疗效和安全性。方法:收集2019年7月至2020年7月既往全身治疗进展或不耐受的晚期肝细胞癌患者24例,给予卡瑞利珠单抗200 mg静脉滴注,每3周给药1次;沙利度胺100 mg起始,1周后增至200 mg,每晚1次口服。评价疗效及安全性。结果:共24例患者纳入研究,其中1例完全缓解,8例部分缓解,9例疾病稳定,4例疾病进展,客观缓解率为37.5%(9/24),疾病控制率为75.0%(18/24)。2例患者在随访期间死亡,死亡原因为疾病进展导致的多器官衰竭,中位PFS为6.5个月(95%CI,5.15~7.85)。最常见的不良反应是反应性皮肤毛细血管增生症(41.7%)、血小板减少(33.4%)、γ-谷氨酰转肽酶升高(25.0%)、白细胞减少(20.8%)和转氨酶升高(29.2%),1例3级血小板减少事件,2例3级转氨酶升高事件,未发现4级及以上的不良反应。结论:卡瑞利珠单抗联合沙利度胺在晚期肝细胞癌患者中显示出一定的疗效和可控的安全性。对于既往全身治疗进展或不耐受的晚期肝细胞癌患者来说,这可能代表了一种新的治疗选择。

Objective:To investigate the safety and clinical efficacy of camrelizumab combined with thalidomide in the treatment of advanced hepatocellular carcinoma.Methods:From July 2019 to July 2020,the clinical data of 24 patients with advanced hepatocellular carcinoma who had progressed on or were intolerant to previous systemic treatment were reviewed.All the patients received intravenous camrelizumab 200 mg every 3 weeks,oral thalidomide 100 mg every night and increased to 200 mg after one week.The efficacy and safety were evaluated comprehensively.Results:A total of 24 patients were finally enrolled in this research.There were 1 case of complete response,8 cases of partial response,9 cases of stable disease and 4 cases of progressive disease.The objective response rate was 37.5%(9/24).The disease control rate was 75.0%(18/24).2 patients died with multiple organ failure due to disease progression during follow-up.The median PFS was 6.5 months(95%CI,5.15~7.85).The most common treatment-related adverse events(AEs)were reactive cutaneous capillary endothelial proliferation(RCCEP)(41.7%),thrombocytopenia(33.4%),increasedγ-glutamyltransferase(25.0%),decreased white blood cell(20.8%)and increased aminotransferase(29.2%).There were 1 case of grade 3 thrombocytopenia and 2 cases of grade 3 increased aminotransferase.No grade 4 AEs was observed.Conclusion:Camrelizumab combined with thalidomide showed promising efficacy and manageable safety in patients with advanced hepatocellular carcinoma.It might represent a novel treatment option for these patients with HCC who had progressed on or were intolerant to previous systemic treatment.