TACE联合贝伐珠单抗和信迪利单抗治疗不可切除肝细胞癌患者临床疗效研究*

doi:10.3969/j.issn.1672-5069.2025.05.028

摘要/Abstract

摘要： 目的观察经肝动脉栓塞化疗(TACE)联合贝伐珠单抗和信迪利单抗治疗不可切除肝细胞癌(HCC)患者的临床疗效。方法 2021年6月～2024年1月我院收治的96例不可切除HCC患者被随机分为两组,每组48例,给予对照组TACE联合信迪利单抗治疗,给予观察组TACE联合贝伐珠单抗和信迪利单抗治疗,3周一个疗程,共治疗4个疗效。采用ELISA法检测血清甲胎蛋白(AFP)、碱性成纤维细胞生长因子(bFGF)、血管内皮生长因子(VEGF)和异常凝血酶原(PIVKA-Ⅱ),使用流式细胞仪检测外周血T淋巴细胞亚群。随访1年。结果在疗程结束时评估,观察组客观缓解率为83.3%,显著高于对照组的62.5%(P<0.05);观察组血清AFP、bFGF、VEGF和PIVKA-Ⅱ水平分别为(77.9±31.7)ng/mL、(4.2±0.8)pg/mL、(82.7±18.3)pg/mL和(652.9±102.4)mAU/L,均显著低于对照组【分别为(169.4±57.4)ng/mL、(5.3±1.0)pg/mL、(124.5±20.9)pg/mL和(764.0±113.9)mAU/L,均P<0.05】;观察组外周血CD4⁺细胞百分比和CD4⁺/CD8⁺比值分别为(34.5±2.8)%和(1.4±0.2),均显著高于对照组【分别为(30.1±3.1)%和(1.2±0.2),均P<0.05】;两组1～3级不良反应发生率比较,差异无统计学意义(P＞0.05);在随访1年末,观察组总体生存率为83.3%,与对照组的68.8%比,差异无统计学意义(P＞0.05),无进展生存率为79.2%,显著高于对照组的58.3%(P<0.05)。结论采用TACE治疗后联合贝伐珠单抗和信迪利单抗治疗不可切除的HCC患者能提高短期临床疗效,可能与调节了免疫功能和抑制了肿瘤血管生成有关。

关键词: 肝细胞癌, 经动脉化疗栓塞, 贝伐珠单抗, 信迪利单抗, 治疗

Abstract: Objective The aim of this study was to investigate clinical efficacy of bevacizumab and sintilimab combination after transcatheter arterial chemoembolization (TACE) in the treatment of patients with unresectable hepatocellular carcinoma (HCC). Methods 96 patients with unresectable HCC were enrolled in our hospital between June 2021 and January 2024, and were randomized into two groups, with 48 cases in each group. Patients in control group were treated with intravenously sintilimab after TACE, and those in the observation were dealt with intranenous bevacizumab and sintilimab combination after TACE for 4 treatment course. Serum alpha-fetoprotein (AFP), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and protein induced by vitamin K absence or antagonist-II (PIVKA-Ⅱ) levels were detected by ELISA, and peripheral blood lymphocyte subsets were detected by flow cytometry. The 1-year overall survival rate and progression-free survival rate were recorded. Results By end of treatment course, the objective remission rate assessed by modified response evaluation criteria in solid tumors in the observation group was 83.3%, significantly higher than 62.5% in the control (P<0.05); serum AFP, bFGF, VEGF and PIVKA-Ⅱ levels in the observation group were (77.9±31.7)ng/mL, (4.2±0.8)pg/mL, (82.7±18.3)pg/mL and (652.9±102.4)mAU/L, all much lower than [(169.4±57.4)ng/mL, (5.3±1.0)pg/mL, (124.5±20.9)pg/mL and (764.0±113.9)mAU/L, respectively, all P<0.05] in the control; percentage of peripheral blood CD4⁺ cells and CD4⁺/CD8⁺ cell ratio were (34.5±2.8)% and (1.4±0.2), both much higher than [(30.1±3.1)% and (1.2±0.2), P<0.05] in the control; incidence of adverse effects in the two groups were not significantly different(P＞0.05); by end of one-year follow-up, the total survival rate in the observation was 83.3%, not significantly different compared to 68.8% in the control (P＞0.05), while the progression-free survival rate was 79.2%, much higher than 58.3%(P<0.05) in the control group. Conclusion Combination of bevacizumab and sintilimab after TACE in the treatment of patients with advanced HCC is short-termly efficacious, which might be related to modulation of body immune functions and inhibition of angiogenesis.

Key words: Hepatocellular carcinoma, Transcatheter arterial chemoembolization, Bevacizumab, Sintilimab, Therapy

穆亚, 葛乃建, 刘学, 王向东, 徐伟, 杨业发. TACE联合贝伐珠单抗和信迪利单抗治疗不可切除肝细胞癌患者临床疗效研究^*[J]. 实用肝脏病杂志, 2025, 28(5): 751-754.

Mu Ya, Ge Naijian, Liu Xue, et al. Clinical efficacy of bevacizumab and sintilimab combination after TACE in the treatment of patients with unresectable hepatocellular carcinoma[J]. Journal of Practical Hepatology, 2025, 28(5): 751-754.

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TACE联合贝伐珠单抗和信迪利单抗治疗不可切除肝细胞癌患者临床疗效研究^*

Clinical efficacy of bevacizumab and sintilimab combination after TACE in the treatment of patients with unresectable hepatocellular carcinoma

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