载药微球经动脉栓塞化疗在巨块型肝癌转化治疗中的疗效及安全性

doi:10.3877/cma.j.issn.2095-3232.2026.01.006

中华肝脏外科手术学电子杂志 ›› 2025, Vol. 15 ›› Issue (01) : 28 -35. doi: 10.3877/cma.j.issn.2095-3232.2026.01.006

临床研究

载药微球经动脉栓塞化疗在巨块型肝癌转化治疗中的疗效及安全性

张龙, 徐伟, 孙善柯, 李文柱, 李俊达, 池涌泉, 宋进华, 王学浩, 成峰, 饶建华^†(

)

210029　南京医科大学第一附属医院（江苏省人民医院）肝胆中心

收稿日期:2025-08-05 出版日期:2025-02-10
通信作者: 饶建华
基金资助:
国家重点实验室（神经与肿瘤药物研发）开放课题(SKLSIM-20251423); 江苏省第六期“333工程”“卡脖子”技术攻关人才项目（成果转化）; 中国医学科学院临床与转化医学研究专项(2023-I2M-CT-B-126); 江苏省人民医院（南京医科大学第一附属医院）临床能力提升工程(JSPH-MB-2023-9); 湖北陈孝平科技发展基金会2024年度肿瘤防治研究槐耳专项基金(CXPJJH124009-080)

Efficacy and safety of drug-eluting beads transarterial chemoembolization in conversion therapy for massive hepatocellular carcinoma

Long Zhang, Wei Xu, Shanke Sun, Wenzhu Li, Junda Li, Yongquan Chi, Jinhua Song, Xuehao Wang, Feng Cheng, Jianhua Rao^†()

Hepatobiliary Disease Center of the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing 210029, China

Received:2025-08-05 Published:2025-02-10
Corresponding author: Jianhua Rao

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引用本文：

张龙, 徐伟, 孙善柯, 李文柱, 李俊达, 池涌泉, 宋进华, 王学浩, 成峰, 饶建华. 载药微球经动脉栓塞化疗在巨块型肝癌转化治疗中的疗效及安全性[J/OL]. 中华肝脏外科手术学电子杂志, 2025, 15(01): 28-35.

Long Zhang, Wei Xu, Shanke Sun, Wenzhu Li, Junda Li, Yongquan Chi, Jinhua Song, Xuehao Wang, Feng Cheng, Jianhua Rao. Efficacy and safety of drug-eluting beads transarterial chemoembolization in conversion therapy for massive hepatocellular carcinoma[J/OL]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2025, 15(01): 28-35.

目的

探讨载药微球经动脉栓塞化疗（DEB-TACE）在巨块型肝细胞癌（肝癌）转化治疗中的疗效及安全性。

方法

回顾性分析2023年1月至12月南京医科大学第一附属医院收治的19例行DEB-TACE转化治疗的巨块型肝癌患者临床病理资料。患者均签署知情同意书，符合医学伦理学规定。其中男13例，女6例；年龄（63±11）岁。CNLC分期Ⅰb期12例，Ⅱb期4例，Ⅲa期3例；肿瘤直径（12.1±1.9） cm。采用回顾性描述性与队列性相结合的研究方法，观察患者肿瘤学及一般情况，DEB-TACE治疗、转化及手术情况，成功组和失败组的随访及生存情况。生存分析采用Kaplan-Meier法和Log-rank检验。

结果

19例患者均顺利完成DEB-TACE治疗，安全性及耐受性良好。其中6例患者转化成功（成功组），转化成功率为32%，5例接受根治性手术，1例评估为完全缓解（CR），拒绝手术；其余13例患者评估为转化不成功（68%，失败组），其中9例评估为疾病稳定（SD），4例评估为疾病进展（PD）。成功组中位OS未达到，失败组中位OS为6个月，差异有统计学意义（χ²=8.054，P=0.005）；成功组中位PFS未达到，失败组中位PFS为4个月，差异有统计学意义（χ²=8.625，P=0.003）。

结论

DEB-TACE转化治疗巨块型肝癌有较高转化率，具有良好的安全性及耐受性，且转化成功能明显延长患者PFS和OS，有较高的临床应用价值。

关键词: 癌，肝细胞, 巨块型肝癌, 转化治疗, 载药微球经动脉化疗栓塞, 治疗相关不良事件

Objective

To evaluate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) in the conversion therapy for massive hepatocellular carcinoma (HCC).

Methods

Clinicopathological data of 19 patients with massive HCC receiving conversion therapy of DEB-TACE in the First Affiliated Hospital of Nanjing Medical University from January to December 2023 were retrospectively analyzed. The informed consents of all patients were obtained and the local ethical committee approval was received. Among 19 patients, 13 were male and 6 female, aged (63±11) years. The study included 12 patients of China Liver Cancer Staging (CNLC) stage Ⅰb, 4 cases of CNLC stage Ⅱb and 3 cases of CNLC stage Ⅲa. The tumor diameter was (12.1±1.9) cm. Retrospective descriptive and cohort study methods were adopted. Tumor status and general conditions of patients, DEB-TACE, conversion treatment, surgery, and follow-up data and survival in success and failure groups were observed. Kaplan-Meier method and Log-rank test were used for survival analysis.

Results

All 19 patients successfully completed DEB-TACE, with high safety and tolerance. Among them, 6 patients obtained successful conversion treatment (success group), and the success rate of conversion treatment was 32%. 5 patients underwent radical surgery, and 1 patient evaluated as complete remission (CR) refused surgery. The remaining 13 patients were assessed as unsuccessful conversion treatment (68%, failure group), including 9 patients were assessed as stable disease (SD) and 4 as progressive disease (PD). The median overall survival (OS) was not achieved in the success group and 6 months in the failure group, with statistical significance between two groups (χ²=8.054, P=0.005). The median progression-free survival (PFS) was not achieved in the success group and 4 months in the failure group, with statistical significance between two groups (χ²=8.625, P=0.003).

Conclusions

DEB-TACE conversion treatment yields high conversion rate, high safety and tolerance. Successful conversion treatment can significantly prolong PFS and OS. This protocol is worthy of clinical application.

Key words: Carcinoma,hepatocellular, Giant hepatocellular carcinoma, Conversion therapy, Drug eluting bead transarterial chemoembolization (DEB-TACE), Treatment related adverse events

表1 巨块型肝癌DEB-TACE转化治疗患者基线数据

项目	数据
性别[例(%)]
男	13(68)
女	6(32)
年龄(岁, $x ¯$ ±s)	63±11
治疗前CNLC分期[例(%)]
Ⅰb 期	12(63)
Ⅱb 期	4(21)
Ⅲa 期	3(16)
肿瘤长径(cm, $x ¯$ ±s)	12.1±1.9
AFP ≥400 μg/L[例(%)]	7(37)
PIVKA-Ⅱ阳性[例(%)]	15(79)
CEA[μg/L, M(Q₁, Q₃)]	2.2(1.4, 4.3)
CA19-9[U/L, M(Q₁, Q₃)]	19 (7, 37)
HBsAg阳性[例(%)]	10(53)
HCV阳性[例(%)]	1(5)
ALT[U/L, M(Q₁, Q₃)]	28 (18, 39)
AST[U/L, M(Q₁, Q₃)]	49(39, 54)
TB[μmol/L, M(Q₁, Q₃)]	12.8(11.6, 18.2)
Child-Pugh分级A级[例(%)]	19(100)
ECOG-PS评分0分[例(%)]	14(74)

表1 巨块型肝癌DEB-TACE转化治疗患者基线数据

项目	数据
性别[例(%)]
男	13(68)
女	6(32)
年龄(岁, $x ¯$ ±s)	63±11
治疗前CNLC分期[例(%)]
Ⅰb 期	12(63)
Ⅱb 期	4(21)
Ⅲa 期	3(16)
肿瘤长径(cm, $x ¯$ ±s)	12.1±1.9
AFP ≥400 μg/L[例(%)]	7(37)
PIVKA-Ⅱ阳性[例(%)]	15(79)
CEA[μg/L, M(Q₁, Q₃)]	2.2(1.4, 4.3)
CA19-9[U/L, M(Q₁, Q₃)]	19 (7, 37)
HBsAg阳性[例(%)]	10(53)
HCV阳性[例(%)]	1(5)
ALT[U/L, M(Q₁, Q₃)]	28 (18, 39)
AST[U/L, M(Q₁, Q₃)]	49(39, 54)
TB[μmol/L, M(Q₁, Q₃)]	12.8(11.6, 18.2)
Child-Pugh分级A级[例(%)]	19(100)
ECOG-PS评分0分[例(%)]	14(74)

图1 巨块型肝癌患者DEB-TACE转化治疗筛选及入组流程注：DEB-TACE为载药微球TACE

表2 巨块型肝癌患者DEB-TACE转化治疗成功后手术治疗情况

例序	性别	年龄(岁)	手术时间(min)	术中输血(U)	手术方式	术后住院(d)	病理评价
1	女	64	330	7	开腹	12	PR
2	男	60	108	/	开腹	7	CR
3	女	74	184	/	开腹	10	PR
4	男	66	215	2	开腹	9	PR
5	女	61	129	/	腹腔镜	7	CR

表2 巨块型肝癌患者DEB-TACE转化治疗成功后手术治疗情况

例序	性别	年龄(岁)	手术时间(min)	术中输血(U)	手术方式	术后住院(d)	病理评价
1	女	64	330	7	开腹	12	PR
2	男	60	108	/	开腹	7	CR
3	女	74	184	/	开腹	10	PR
4	男	66	215	2	开腹	9	PR
5	女	61	129	/	腹腔镜	7	CR

图2 巨块型肝癌患者DEB-TACE典型治疗情况注：a、b为DEB-TACE治疗前CT示肿瘤明显强化；c、g为术后标本及病理（HE，×100），提示肿瘤大部分（>90%）坏死；d、h为拒绝手术患者动脉造影提示达CR；e、f为DEB-TACE治疗后CT示肿瘤PR；DEB-TACE为载药微球TACE，PR为部分缓解，CR为完全缓解

图3 两组巨块型肝癌患者DEB-TACE转化治疗后Kaplan-Meier生存曲线注：DEB-TACE为载药微球TACE

表3 成功组与失败组巨块型肝癌临床资料比较（例）

项目	成功组	失败组	P值^a
性别			0.241
男	3	10
女	3	3
年龄(岁)			0.255
≥60	6	9
＜60	0	4
AFP(μg/L)			0.830
≥400	2	5
＜400	4	8
门静脉癌栓			0.200
有	0	3
无	6	10
肝内子灶			0.750
有	1	3
无	5	10
HBsAg			0.350
阳性	2	8
阴性	4	5
联合用药			0.911
有	4	9
无	2	4

表3 成功组与失败组巨块型肝癌临床资料比较（例）

项目	成功组	失败组	P值^a
性别			0.241
男	3	10
女	3	3
年龄(岁)			0.255
≥60	6	9
＜60	0	4
AFP(μg/L)			0.830
≥400	2	5
＜400	4	8
门静脉癌栓			0.200
有	0	3
无	6	10
肝内子灶			0.750
有	1	3
无	5	10
HBsAg			0.350
阳性	2	8
阴性	4	5
联合用药			0.911
有	4	9
无	2	4

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Efficacy and safety of drug-eluting beads transarterial chemoembolization in conversion therapy for massive hepatocellular carcinoma

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Efficacy and safety of drug-eluting beads transarterial chemoembolization in conversion therapy for massive hepatocellular carcinoma