目的：重新评价卡瑞利珠单抗联合阿帕替尼治疗原发性肝癌（PHC）的有效性和安全性。方法：回顾性收集2019 年1月至2021 年5月在安徽医科大学附属第一医院确诊的PHC患者的临床资料。所有患者均接受卡瑞利珠单抗200 mg q3w联合阿帕替尼250 mg qd×21 d治疗。应用卡方检验进行基线特征比较，采用Kaplan-Meier 法进行生存分析，从中估计中位总生存期（OS），然后采用Log-Rank 检验进行比较；采用单因素Cox 回归分析预测影响OS的因素。结果：本研究共纳入43 例PHC患者，一线治疗患者的客观缓解率（ORR）为23.3%（7/30），二线及以上治疗患者的ORR 为15.4%（2/13）。两组患者的疾病控制率（DCR）分别为83.3%（25/30）和61.5%（8/13），中位无进展生存期（PFS）分别为5.0个月（95% CI 3.2，6.8）和4.0 个月（95% CI 1.7， 6.3）（P=0.514），中位OS 分别为13.0 个月（95% CI 11.2，14.8）和9.0 个月（95% CI 2.8，15.2）（P=0.179）。在43 例患者中，33 例（76.7%）存在3 级或以上的治疗相关不良反应（AE）；最常见的AE为血小板计数下降（14.0%）、高血压（9.3%）和蛋白尿（9.3%）。 Cox 单因素回归分析显示，Child-Pugh 分级是影响PHC 患者预后的独立危险因素[HR=0.324，95% CI（0.146，0.716），P<0.05]。结论：卡瑞利珠单抗联合阿帕替尼可显著改善PHC患者的OS、ORR和DCR，AE可控。

Objective: To reevaluate the efficacy and safety of camrelizumab combined with apatinib in the treatment of primary hepatic carcinoma (PHC). Methods: The clinical data of PHC patients diagnosed in the First Affiliated Hospital of Anhui Medical University from January 2019 to May 2021 were retrospectively collected. All patients received camrelizumab 200 mg q3w combined with apatinib 250 mg qd for 21 days. Chi-square test was used to compare the baseline characteristics. Kaplan-Meier method was used to calculate the survival curve, from which the median total survival (OS) was estimated, and then Log-Rank test was used for comparison; Single factor Cox regression analysis was used to predict the factors affecting OS. Results: A total of 43 patients with PHC were included in this study. The objective response rate (ORR) of first-line treatment patients was 23.3% (7/30), and the ORR of second-line and above treatment patients was 15.4% (2/13). The disease control rate (DCR) of the two groups were 83.3% (25/30) and 61.5%(8/13), respectively. The median progression-free survival (PFS) was 5.0 months (95% CI 3.2, 6.8) and 4.0 months (95% CI 1.7, 6.3) (P=0.514), respectively. The median total survival (OS) was 13.0 months (95% CI 11.2, 14.8) and 9.0 months (95% CI 2.8, 15.2) (P=0.179). Among 43 patients, 33 (76.7%) had treatment-related AEs of grade 3 or above. The most common AEs were decreased platelet count (14.0%), hypertension (9.3%) and proteinuria (9.3%). Cox univariate analysis showed that Child-Pugh grade was an independent risk factor affecting the prognosis of PHC patients (HR=0.324, 95% CI [0.146, 0.716], P<0.05). Conclusion: Camrelizumab plus apatinib significantly improved OS, ORR, and DCR in PHC patients , AEs were tolerable and manageable.

安徽省高校自然科学基金（No.KJ2021A0300）