Objective  To explore the clinical efficacy and safety of sintilimab combined with bevacizumab in the treatment of advanced hepatocellular carcinoma (HCC).

Methods  Patients with advanced HCC diagnosed and treated in Xuzhou Cancer Hospital from January 2021 to January 2023 were retrospectively selected as study subjects. According to the treatment regimen, patients with advanced HCC were categorized into the sorafenib group (sorafenib treatment) and the monoclonal antibody group (sindilizumab+bevacizumab treatment). The primary study endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary study endpoints were objective response rate (ORR) and disease control rate (DCR). The occurrence of adverse reactions was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE 4.03).

Results   A total of 108 patients with advanced HCC were enrolled, 36 in the sorafenib group and 72 in the monoclonal antibody group. The median PFS and OS were significantly higher in the monoclonal antibody group than in the sorafenib group (P<0.05). The ORR in the monoclonal antibody group was significantly higher than that in the sorafenib group (P<0.05), but the difference in DCR between the two groups was not statistically significant (P>0.05). Regarding adverse reactions, no fatal adverse reactions occurred in both groups, and the occurrence of adverse reactions was similar.

Conclusion  Compared with sorafenib, sindilizumab combined with bevacizumab resulted in better OS and PFS in advanced HCC with a favorable safety profile.

1.Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2018, 68: 394-424. DOI: 10.3322/caac.21492.

2.Cheng K, Ho K. Laparoscopic vs open liver re-resection for cirrhotic patients with post-hepatectomy hepatocellular carcinoma recurrence: a comparative study[J]. World J Gastrointest Surg, 2022, 14(5): 409-418. DOI: 10.4240/wjgs.v14.i5.409.

3.吴霜霜, 戚益铭, 朱红, 等. 晚期肝细胞癌肝动脉灌注化疗与索拉非尼靶向治疗疗效比较的Meta分析[J]. 浙江医学, 2021, 43(6): 639-644. [Wu SS, Qi YM, Zhu H, et al. Meta-analysis of the efficacy of hepatic arterial infusion chemotherapy and sorafenib targeted therapy in advanced hepatocellular carcinoma[J]. Zhejiang Medical Journal, 2021, 43(6): 639-644.] DOI: 10.12056/j.issn.1006-2785.2021.43.6.2020-3667.

4.单东凤. HAX-1通过BTBD7介导的上皮—间质转化促进肺腺癌的进展[D]. 山东青岛: 青岛大学, 2021.

5.Llovet JM, Ducreux M, Lencioni R, et al. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma[J]. Eur J Cancer. 2012, 48(5): 599-641. DOI: 10.1016/j.jhep.2011.12.001.

6.Hatanaka T, Arai H, Kakizaki S. Balloon-occluded transcatheter arterial chemoembolization for hepatocellular carcinoma[J]. World Journal of Hepatology, 2018, 10(7): 485-495. DOI: 10.4254/wjh. v10. i7.485.

7.Xie Y, Tian H, Xiang H. Is transcatheter arterial chemoembolization plus sorafenib better than chemoembolization plus placebo in the treatment of hepatocellular carcinoma?[J]. Tumori, 2021, 107(4): 292-303. DOI: 10.1177/0300891620945029.

8.中华人民共和国国家卫生健康委员会. 原发性肝癌诊疗指南(2022年版)[J]. 肿瘤综合治疗电子杂志, 2022, 8(2): 16-53. DOI: 10.12151/JMCM.2022.02-04.

9.Ren ZG, Xu JM, Bai YX, et al. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study[J]. Lancet Oncol, 2021, 22(7): 977-990. DOI: 10.1016/S1470-2045(21) 00252-7.

10.周柳旦. 贝伐珠单抗联合信迪利单抗治疗肝癌的临床疗效观察[J]. 福建医药杂志, 2023, 45(2): 50-53. [Zhou LD. Clinical efficacy observation of bevacizumab combined with Xindilizumab in the treatment of liver cancer[J]. Fujian Medical Journal, 2023, 45(2): 50-53.] DOI: 10.3969/j.issn.1002-2600.2023.02.016.

11.柴喆. 信迪利单抗联合贝伐珠单抗联合肝动脉化疗栓塞术治疗不可切除肝癌的疗效及对血清肿瘤相关因子的影响[J]. 临床研究, 2023, 31(6): 84-86. [Chai Z. The therapeutic effect of Xindilizumab combined with bevacizumab and hepatic artery chemoembolization in the treatment of unresectable liver cancer and its impact on serum tumor related factors[J]. Clinical Research, 2023, 31(6): 84-86.] DOI: 10.12385/j.issn.2096-1278(2023) 06-0084-03.

12.Samuel GA, Anna KN. Revised modified response evaluation criteria in solid tumors for assessment of response in malignant pleural mesothelioma (version1.1)[J]. J Thorac Oncol, 2018, 13(7): 1012-1021. DOI: 10.1016/j. jtho.2018.04.034.

13.Méndez-blanco C, Fondevila F, García-Palomo A, et al. Sorafenib resistance in hepatocarcinoma: role of hypoxia-inducible factors[J]. Exp Mol Med, 2018, 50(10): 1-9. DOI: 10.1038/s12276-018-0159-1.

14.Nishino M, Jackman DM, Hatabu H, et al. New response evaluation criteria in solid tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy[J]. AJR Am J Roentgenol, 2010, 195(3): W221-W228. DOI: 10.2214/AJR.09.3928.