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目的 探讨信迪利单抗联合仑伐替尼和体外放射治疗不可切除肝癌患者的疗效。方法 采用前瞻性随机对照研究方法，纳入102例新乡医学院第一附属医院2020年1月至2024年12月就诊的不可切除肝癌患者，采用随机数字表法将其分为两组，各51例。对照组接受信迪利单抗+仑伐替尼治疗，试验组接受信迪利单抗+仑伐替尼+体外放射治疗。治疗6个周期(18周)后，比较两组的临床疗效、肿瘤指标、免疫指标、生活质量评分及不良反应发生率。结果 治疗后，试验组客观缓解率高于对照组[70.59%(36/51) vs 41.18%(21/51)，χ2=8.947,P<0.05]。对照组和试验组疾病控制率差异无统计学意义[82.35%(42/51) vs 92.16%(47/51)，χ2=2.204,P>0.05]。治疗后，试验组甲胎蛋白、异常凝血酶原水平均低于对照组[(121.72±13.73)μg/L、(18.06±3.57)mAU/mL vs(142.57±13.73)μg/L、(29.57±4.33)mAU/mL,t=7.668、14.647，均P<0.05]。治疗后，试验组CD3+、CD4+水平、CD4+/CD8+比值均高于对照组[(73.08±6.22)%、(56.58±5.12)%、(1.63±0.29) vs(69.02±6.12)%、(51.63±4.87)%、(1.35±0.23),t=3.323、5.003、5.402，均P<0.05]。治疗后，试验组整体健康状况、功能量表评分均高于对照组[(71.95±11.42)、(416.51±66.31)分vs(64.33±11.26)、(388.42±66.13)分，t=3.393、2.142，均P<0.05]，症状量表评分均低于对照组(t=2.988,P<0.05)。对照组和试验组不良反应发生率比较[64.71%(33/51) vs80.39%(41/51)]，差异均无统计学意义(χ2=3.151,P>0.05)。结论 对于不可切除肝癌患者，信迪利单抗联合仑伐替尼及体外放射治疗可提高客观缓解率，降低甲胎蛋白和异常凝血酶原水平，改善免疫功能及生活质量，安全性良好。
Abstract：Objective To investigate the efficacy of sintilimab combined with lenvatinib and external beam radiotherapy in patients with unresectable hepatocellular carcinoma. Methods A prospective randomized controlled study was conducted. A total of 102 patients with unresectable hepatocellular carcinoma treated at the First Affiliated Hospital of Xinxiang Medical University from January 2020 to December 2024 were enrolled and divided into two groups using a random number table method, with 51 cases in each group. The control group received sintilimab plus lenvatinib, while the experimental group received sintilimab plus lenvatinib combined with external beam radiotherapy. After 6 cycles of treatment, clinical efficacy, tumor markers, immunological indicators, quality of life scores, and incidence of adverse reactions were compared between the two groups. Results After treatment, the objective response rate in the experimental group was significantly higher than that in the control group(70.59%(36/51) vs 41.18%(21/51), χ2=8.947, P<0.05). The comparison of disease control rates between the control group and the experimental group showed no statistically significant difference(82.35%(42/51) vs 92.16%(47/51), χ2=2.204, P>0.05). After treatment, the levels of alpha-fetoprotein and protein induced by vitamin K absence or antagonist-Ⅱ(PIVKA-Ⅱ) in the experimental group were lower than those in the control group((121.72±13.73) μg/L,(18.06±3.57) mAU/mL vs(142.57±13.73) μg/L,(29.57±4.33) mAU/mL, t=7.668, 14.647, both P<0.05). After treatment, the experimental group showed higher levels of CD3+, CD4+, and CD4+/CD8+ ratio compared to the control group((73.08±6.22)%,(56.58±5.12)%,(1.63±0.29) vs(69.02±6.12)%,(51.63±4.87)%,(1.35±0.23), t=3.323, 5.003, 5.402, all P<0.05). After treatment, the experimental group showed higher global health status and functional scale scores compared to the control group((71.95±11.42),(416.51±66.31) points vs(64.33±11.26),(388.42±66.13) points, t=3.393, 2.142, both P<0.05), while the symptom scale scores were lower than those in the control group(t=2.988, P<0.05). The comparison of adverse reaction incidence rates between the control group and the experimental group showed no statistically significant difference(64.71%(33/51) vs 70.59%(36/51), χ2=3.151, P>0.05). Conclusion The combination of sintilimab, lenvatinib, and external beam radiotherapy for unresectable hepatocellular carcinoma can improve objective response rate, reduce alpha-fetoprotein and PIVKA-Ⅱ levels, enhance immune function and quality of life, with a favorable safety profile.
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基本信息:
中图分类号:R735.7
引用信息:
[1]庞克华,杨军,王守宇,等.信迪利单抗联合仑伐替尼和体外放射治疗不可切除肝癌的疗效[J].中国药物应用与监测,2026,23(04):465-469.
基金信息:
河南省科学技术厅2024年科技发展计划项目（242102310487）
2026-04-07
2026-04-07
2026-04-07