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中华介入放射学电子杂志

中华介入放射学电子杂志 ›› 2026, Vol. 14 ›› Issue (03) : 221 -234. doi: 10.3877/cma.j.issn.2095-5782.2026.03.001

系统综述/Meta分析

经导管介入联合靶免对比单纯靶免治疗不可切除肝癌患者的Meta分析
黄庭熙1, 张柳婧1, 谭文乐2, 朱旗2, 段峰1,2,†()   
  1. 1　100853　北京，解放军医学院
    2　100039　北京，解放军总医院第一医学中心介入放射科
  • 收稿日期:2026-03-18 出版日期:2026-08-25
  • 通信作者: 段峰

Transcatheter Interventional Therapy Combined with Targeted Immunotherapy versus Targeted Immunotherapy Alone in Patients with Unresectable Hepatocellular Carcinoma: A Meta-analysis

Tingxi Huang1, Liujing Zhang1, Wenle Tan2, Qi Zhu2, Feng Duan1,2,†()   

  1. 1 Chinese PLA Medical School, Beijing 100853, China
    2 Department of Interventional Radiology, the First Medical Center of PLA General Hospital, Beijing 100039, China
  • Received:2026-03-18 Published:2026-08-25
  • Corresponding author: Feng Duan
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引用本文：

黄庭熙, 张柳婧, 谭文乐, 朱旗, 段峰. 经导管介入联合靶免对比单纯靶免治疗不可切除肝癌患者的Meta分析[J/OL]. 中华介入放射学电子杂志, 2026, 14(03): 221-234.

Tingxi Huang, Liujing Zhang, Wenle Tan, Qi Zhu, Feng Duan. Transcatheter Interventional Therapy Combined with Targeted Immunotherapy versus Targeted Immunotherapy Alone in Patients with Unresectable Hepatocellular Carcinoma: A Meta-analysis[J/OL]. Chinese Journal of Interventional Radiology(Electronic Edition), 2026, 14(03): 221-234.

目的

评价经导管介入联合靶免治疗对比单纯靶免治疗不可切除肝细胞癌的疗效和安全性。

方法

检索Cochrane图书库、PubMed及Embase数据库，检索时间从建库日至2026年1月。搜集相关文献，由2名研究者按纳入与排除标准进行文献筛选和质量评估。使用RevMan 5.3进行Meta分析。根据异质性检验结果选择固定或随机效应模型合并数据。设定亚组分析探索异质性来源，并通过敏感性分析、漏斗图及Egger/Begg检验评估发表偏倚，采用剪补法校正潜在偏倚。最后采用GRADE系统对主要结局指标进行证据质量分级。

结果

共纳入文献18篇，共计患者3 168例，其中联合治疗组患者1 794例，单纯靶免治疗组患者1 374例。联合治疗组的完全缓解率（OR=2.69，95% CI: 1.45~4.99）、客观缓解率（OR=2.75，95% CI: 2.35~3.22）、疾病控制率（OR=2.61，95% CI: 1.78~3.83）较高，无进展生存期（HR=0.56，95% CI: 0.48~0.65）及总生存期（HR=0.5, 95% CI: 0.44~0.57）较长。安全性方面，联合治疗组丙氨酸氨基转移酶、天门冬氨酸氨基转移酶升高，高胆红素血症、恶心呕吐及腹痛的发生率显著升高。

结论

经导管介入联合靶向免疫治疗可能提升不可切除肝细胞癌的局部控制率和远期生存期，但受限于现有研究质量与数量，未来还需更多大样本、多中心和前瞻性的研究进一步验证其疗效与安全性，为临床个体化治疗提供更高等级的循证医学依据。

关键词: 肝细胞癌, 介入放射学, 分子靶向治疗, 免疫检查点抑制剂, Meta分析
Objective

To evaluate the efficacy and safety of transcatheter interventional therapy combined with targeted and immune therapy versus targeted and immune therapy alone in the treatment of unresectable hepatocellular carcinoma.

Methods

A systematic review and meta-analysis conforming to PRISMA guidelines were conducted by searching the Cochrane Library, PubMed, and Embase databases up to January 2026. Relevant literature was collected, and two researchers conducted literature screening and quality assessment according to the inclusion and exclusion criteria. The meta-analysis was performed using RevMan 5.3.

Results

A total of 18 studies were included, involving 3 168 patients, with 1 794 in the combination therapy group and 1,374 in the single targeted-immunotherapy group. The combination therapy group showed higher complete response rate (OR=2.69, 95% CI: 1.45–4.99), objective response rate (OR=2.75, 95% CI: 2.35–3.22), and disease control rate (OR=2.61, 95% CI: 1.78–3.83), as well as longer progression-free survival (HR=0.56, 95% CI: 0.48–0.65) and overall survival (HR=0.5, 95% CI: 0.44–0.57). Regarding safety, the combination therapy group had significantly higher rates of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), hyperbilirubinemia, nausea/vomiting, and abdominal pain.

Conclusion

The findings suggest that the transcatheter interventional therapy combined with targeted immunotherapy can improve the local control rate and long-term survival rate of unresectable HCC.

Key words: Hepatocellular carcinoma, Radiology, Interventional, Molecular Targeted Therapy, Immune Checkpoint Inhibitors, Meta-analysis
图1 文献纳入排除流程
表1 纳入研究的文献纽卡斯尔-渥太华量表（NOS）质量评分
研究 选择 可比性 结局 得分（总分9分）
暴露队列的代表性（1分） 对照队列的选择（1分） 暴露的确定（1分） 研究开始时结局尚未发生（1分） 基于设计或分析所得的队列可比性（2分） 结局评估（1分） 随访时间足够长以观察到结局发生（1分） 队列随访的充分性（1分）
Zhang,Hua等2024[17] 1 1 1 1 2 1 1 1 9
Wu,Yang等2025[18] 1 1 1 1 2 1 1 1 9
Lin,Chen等2025[19] 1 1 1 1 2 1 1 1 9
Li,Wang等2024[20] 1 1 1 1 2 1 0 1 8
Huang,Zhong等 2022[21] 1 1 1 1 2 1 1 1 9
Chen,Wang等2025[22] 1 1 1 1 2 1 1 1 9
Chen,Xu等2021[23] 1 1 1 1 1 1 1 1 8
Yang,Deng等2023[24] 1 1 1 1 2 1 0 1 8
Wang,Zhao等2023[25] 1 1 1 1 2 1 0 1 8
Shen,Shao等2025[26] 1 1 1 1 2 1 1 1 9
Pan,Ruan 等2025[27] 1 1 1 1 2 1 1 1 9
Lei,Bai等2025[28] 1 1 1 1 1 1 0 1 7
Yin,Li等2025[29] 1 1 1 1 2 1 0 1 8
Wang,Zhang等2024[30] 1 1 1 1 1 1 0 1 7
Mei,Tang等2021[31] 1 1 1 1 1 1 0 1 7
Lou,Zhang等2025[32] 1 1 1 1 1 1 0 1 7
Liu,Wang等2025[33] 1 1 1 1 1 1 0 1 7
Diao,Wang等2024[34] 1 1 1 1 1 1 1 1 8
表2 纳入文献的详细数据
研究 设计类型 治疗方案 例数 年龄（岁，例数/均数±标准差/中位数） 性别(男性/女性，例) HBV(P/N，例) Child-Pugh, A/B(例) 甲胎蛋白(<400/≥400，ng/mL) VI(是/否，例) 肝外转移(是/否，例) BCLC 分期, A/B/C(例) CR, N [例(%)] ORR,N [例(%)] DCR, N [例(%)] 中位无进展生存期(月) 中位总生存期(月)
Zhang,Hua等2024 after PSM[17] 回顾性多中心 TACE+TKI+ICI 54 ≤60/>60(38/16) 46/8 53/1 54/0 26/28 22/32 19/35 0/23/31 1(1.9) 34(63.0) 46(85.2) 9.9 NR
TKI+ICI 54 ≤60/>60(37/17) 47/7 52/2 54/0 29/25 20/34 20/34 0/21/33 0(0.0) 16(29.6) 29(53.7) 5.8 18.5
Wu,Yang等2025 after PSM[18] 回顾性多中心 HAIC+Lenvatinib+PD-1 66 <60/≥60(53/13) 63/3 62/4 58/8 24/42 66/0 21/45 0/0/66 0(0.0) 40(60.6) 63(95.4) 8.4 21.1
Lenvatinib+PD-1 76 <60/≥60(62/14) 71/5 72/4 62/14 33/43 76/0 20/56 0/0/76 1(1.3) 22(28.9) 59(77.6) 5.6 11.5
Lin,Chen等2025 after PSM[19] 回顾性多中心 Systemic+TACE 479 ≤65/>65(265/214) 436/43 394/85 339/80 205/274 479/0 136/343 NA 15(0.3) 257(53.6) 391(81.6) 10.7 20.9
Systemic alone 267 ≤65/>65(142/125) 242/25 223/44 216/51 110/157 267/0 82/185 NA 0(0.0) 97(36.3） 172(64.4) 7.5 14.3
Li,Wang等2024 after [20]PSM 回顾性多中心 HAIC+Lenvatinib+PD1 81 ≤60/>60(72/9) 68/13 NA NA 27/54 67/14 38/43 0/11/70 4(4.9) 41(50.6) 57(70) 7.6 17.8
Lenvatinib+PD-1 81 ≤60/>60(68/13) 69/12 NA NA 27/54 69/12 40/41 0/8/73 0(0.0) 21(25.9) 67(83) 5.6 13.9
Huang,Zhong等 2022 after PSM[21] 回顾性单中心 TACE+ICIs+TKIs 24 58.0±10.7 20/4 20/4 18/6 12/12 18/6 9/15 0/0/24 1(4.2) 10(41.7) 19(79.2) 7.4 17.3
ICIs+TKIs 24 56.5±14.0 21/3 20/4 14/10 15/9 18/6 13/11 0/0/24 0(0.0) 3(12.5) 12(50.0) 6.7 11.8
Chen .Wang等2025 after PSM[22] 回顾性多中心 HAIC+Lenvatinib+PD-1 151 49±12 133/18 139/12 132/19 57/94 99/52 151/0 0/0/151 0(0.0) 72(47.7) 130(86.1) 7.6 26.0
Lenvatinib+PD-1 151 49±12 131/20 138/13 132/19 55/96 97/54 151/0 0/0/151 0(0.0) 31(20.5) 109(72.2) 5.5 8.4
Chen,Xu等2021[23] 回顾性 多中心 Pembrolizumab+Lenvatinib+HAIC 84 52(42~67) 72/12 45/39 71/13 NA 49/35 20/64 0/22/62 13(15.5) 50(59.5) 74(88.1) 10.9 17.7
Pembrolizumab+Lenvatinib 86 53(43~69) 71/15 48/38 75/11 NA 55/31 24/62 0/21/65 8(9.3) 36(41.9) 71(82.6) 6.8 12.6
Yang,Deng等2023 after PSM[24] 回顾性 单中心 Regorafenib+ICIs+TACE 23 53(43~65) 20/3 19/4 22/1 15/8 10/13 11/12 0/9/14 0(0.0) 8(34.8) 16(69.6) 5.8 15.0
Regorafenib+ICIs 23 49(45~56) 19/4 16/7 18/5 14/9 8/15 12/11 0/5/18 0(0.0) 1(4.3) 10(43.5) 2.6 7.5
Wang,Zhao等2023 after PSM[25] 回顾性 单中心 TACE+Lenvatinib+ICIs 43 57.07±10.53 38/5 NA 35/8 25/18 19/24 22/21 0/8/35 0(0.0) 24(55.8) 37(86.0) 10.2 20.5
Lenvatinib+ICIs 43 58.00±10.52 37/6 NA 33/10 21/22 18/25 25/18 0/7/36 0(0.0) 13(30.2) 28(65.1) 7.4 12.6
Shen,Shao等2025 after PSM[26] 回顾性 单中心 HAIT+Lenvatinib+PD-1 74 ≤65/>65(61/13) 64/10 45/29 63/11 30/44 74/0 9/65 0/0/74 1(1.4) 28(37.8) 58(78.4) 10 19
Lenvatinib+PD-1 74 ≤65/>65(59/15) 64/10 46/28 64/10 25/49 74/0 8/66 0/0/74 1(1.4) 12(16.2) 35(47.3) 4 14
Pan,Ruan 等2025 after PSM[27] 回顾性 单中心 ICI+TKI+TACE 60 ≥60/<60(42/18) 49/11 55/5 52/8 40/20 19/41 26/34 9/18/33 NA 10(16.6) 30(50) 8.4 26.9
ICI+TKI 60 ≥60/<60(47/13) 52/8 57/3 52/8 40/20 23/37 30/30 7/11/42 NA 13(21.6) 44(73) 6.6 24.2
Lei,Bai等2025[28] 回顾性 多中心 TACE+TKI+ICI 210 <65/≥65(187/23) 182/28 171/39 159/51 120/90 否 否 4/29/177 4(1.9) 86(56.7) 177(84.3) 8.4 14.5
TKI+ICI 76 <65/≥65(62/14) 63/13 59/17 54/22 45/31 否 否 4/14/58 1(1.3) 16(21.1) 55(72.4) 4.0 10.0
Yin,Li等2025 after sIPTW[29] 回顾性 单中心 TACE-HAIC+Donafenib+ICIs 122 56.86±9.08 101/21 95/27 97/25 49/73 104/18 89/33 0/0/122 NA 83(68.4) 112(92.3) 16.4 29.4
Targeted+ICIs 71 56.63±8.58 63/8 52/19 56/15 30/41 59/12 50/21 0/0/71 NA 20(28.0) 45(63.1) 10.0 18.0
Wang,Zhang等2024[30] 回顾性 单中心 HAIC+PD-1+TKIs 99 56.40±8.70 81/18 99/0 70/29 45/54 59/40 65/34 NA 0(0.0) 53(53.5) 94(94.9) 9.20 18.10
PD-1+TKIs 95 57.11±8.60 78/17 95/0 72/23 51/44 57/38 71/24 NA 0(0.0) 30(31.6) 79(83.2) 6.33 12.57
Mei,Tang等2021[31] 回顾性 单中心 HAIC+PD-1+Lenvatinib 45 49.1±10.6 38/7 37/8 44/1 NA 36/9 15/30 0/5/40 0(0.0) 18(40.0) 38(77.6) 8.8 15.9
PD-1+Lenvatinib 25 50.1±12.3 18/7 19/6 22/3 NA 18/7 13/12 0/3/22 0(0.0) 4(16.0) 11(44.0) 5.4 8.6
Lou,Zhang等2025[32] 回顾性 单中心 HAIC+Lenvatinib+PD-1 67 56.15±7.78 61/6 59/8 56/11 <1000/≥1000: 34/33 41/26 49/27 0/0/67 3(4.5) 46(68.7) 62(92.5) 13.8 22.2
Lenvatinib+PD-1 48 53.48±10.39 44/4 36/12 37/11 28/20 26/22 36/13 0/0/48 1(2.1) 18(37.5) 36(75.0) 5.1 14.4
Liu,Wang等2025[33] 回顾性 单中心 TACE+ICI+anti-VEGF/TKI 54 61(55~66) 42/12 44/10 44/10 ≤200/>200: 33/21 37/17 25/29 0/0/54 NA NA NA 14.7 18.3
ICI+anti-VEGF/TKI 57 60(50~66) 48/9 37/20 48/9 27/30 39/18 34/23 0/0/57 NA NA NA 11.2 11.8
Diao,Wang等2024[34] 回顾性 单中心 HAIC+Lenvatinib+ICI 58 ≤50/>50(16/52) 49/9 47/11 49/9 28/30 32/26 19/39 0/24/34 1(1.7) 28(48.3) 51(87.9) 13.0 24.0
Lenvatinib+ICI 63 ≤50/>50(5/27) 50/13 52/11 55/8 31/32 30/33 21/42 0/25/38 0(0.0) 15(23.8) 44(69.8) 7.2 13.0
图2 介入联合靶免对比单纯靶免治疗不可切除肝癌疗效与生存指标森林图 图2A：完全缓解率森林图；图2B：客观缓解率森林图；图2C：疾病控制率森林图；图2D：无进展生存期森林图；图2E：总生存期森林图。
图3 介入联合靶免对比单纯靶免治疗不可切除肝癌疗效与生存指标漏斗图 图3A：完全缓解率漏斗图；图3B：客观缓解率漏斗图；图3C：疾病控制率漏斗图；图3D：无进展生存期漏斗图；图3E：总生存期漏斗图。
表3 纳入研究文献的主要结局发表偏移情况
结局指标 纳入文献数 I2 OR/HR(95% CI) Egger检验 Begg检验
CR 10 0% 2.69(1.45~4.99) 0.454 6 0.420 8
ORR 17 30% 2.75(2.35~3.22) 0.103 6 0.117 5
DCR 17 73% 2.61(1.78~3.83) 0.410 7 0.138 1
PFS 16 65% 0.56(0.48~0.65) 0.019 9 0.005 2
OS 18 42% 0.50(0.44~0.57) 0.092 4 0.102 9
图4 介入联合靶免对比单纯靶免治疗不可切除肝癌疗效与生存指标敏感性分析图 图4A：完全缓解率的敏感性分析图；图4B：客观缓解率的敏感性分析图；图4C：疾病控制率的敏感性分析图；图4D：无进展生存期的敏感性分析图；图4E：总生存期的敏感性分析图。
表4 纳入研究文献的主要结局指标GRADE证据质量分级
结局指标 纳入研究数 核心降级原因 GRADE证据质量等级
CR 10 均为回顾性研究（偏倚风险）、纳入文献数少 中
ORR 17 均为回顾性研究（偏倚风险） 中
DCR 17 均为回顾性研究（偏倚风险）、高异质性（I2=73%） 低
PFS 16 均为回顾性研究（偏倚风险）、中高异质性（I2=65%）、存在发表偏倚 低
OS 18 均为回顾性研究（偏倚风险）、轻度异质性（I2=42%） 中
表5 不同介入方式、肿瘤特征及靶向药物亚组的疗效分析
终点指标 纳入文献数 参与人数 HR/OR (95% CI) I2 P值 效应模型
TACE联合靶免对比单独靶免治疗
CR 4 1 188 5.35(1.42~20.13) 0% 0.52 Fixed
ORR 7 1 440 2.46(1.59~3.78) 51% 0.06 Random
DCR 7 1 440 2.18(1.18~4.02) 77% <0.001 Random
PFS 6 811 0.66(0.58~0.75) 11% 0.35 Fixed
OS 8 1 551 0.59(0.52~0.68) 31% 0.18 Fixed
HAIC联合靶免对比单独靶免治疗
CR 6 858 1.97(0.96~4.04) 0% 0.78 Fixed
ORR 9 1 424 3.04(2.42~3.82) 0% 0.95 Fixed
DCR 9 1 424 2.73(1.58~4.74) 63% 0.004 Random
PFS 9 1 424 0.53(0.42~0.66) 76% <0.001 Random
OS 9 1 424 0.47(0.42~0.53) 36% 0.13 Fixed
肝外转移
PFS 6 1 347 0.60(0.40~0.89) 65% 0.01 Random
OS 8 1 554 0.68(0.55~0.85) 39% 0.12 Fixed
无肝外转移
PFS 6 1 347 0.51(0.39~0.67) 64% 0.02 Random
OS 8 1 554 0.50(0.43~0.58) 0% 0.56 Fixed
Child-Pugh A级
PFS 7 1 694 0.50(0.37~0.67) 81% <0.001 Random
OS 9 1 904 0.45(0.35~0.58) 66% 0.003 Random
Child-Pugh B级
PFS 7 1 694 0.66(0.51~0.87) 0% 0.54 Fixed
OS 9 1 904 0.60(0.46~0.79) 0% 0.78 Fixed
血管侵犯
PFS 5 728 0.56(0.40~0.78) 56% 0.06 Random
OS 7 935 0.46(0.38~0.56) 30% 0.20 Fixed
无血管侵犯
PFS 5 728 0.70(0.54~0.90) 31% 0.21 Fixed
OS 7 935 0.50(0.37~0.67) 0% 0.94 Fixed
靶向治疗仅仑伐替尼单药
PFS 9 1 316 0.52(0.41~0.66) 76% <0.001 Random
OS 9 1 316 0.46(0.41~0.53) 35% 0.14 Fixed
表6 治疗相关不良事件发生风险的分析结果
不良事件 所有级别 3级及以上
纳入文献数 OR(95% CI) P值 纳入文献数 OR(95% CI) P值
高血压 15 0.97(0.82~1.15) 1.00 14 0.96(0.69~1.34) 0.98
乏力 16 1.18(1.00~1.40) 0.72 15 1.03(0.69~1.54) 0.97
食欲减退 14 1.41(1.17~1.69) 0.15 13 1.55(0.90~2.67) 0.30
发热 8 1.97(1.13~3.44) 0.006 7 1.80(0.58~5.63) 0.92
体质量下降 5 1.18(0.95~1.48) 0.45 5 1.65(0.80~3.40) 0.24
手足皮肤反应 9 1.06(0.82~1.38) 0.88 9 1.47(0.79~2.74) 0.75
皮疹 15 1.31(1.04~1.64) 0.99 14 1.34(0.84~2.11) 0.96
RCCEP 5 1.08(0.69~1.70) 0.55 5 0.73(0.18~2.91) 0.95
蛋白尿 10 1.16(0.92~1.47) 0.82 10 1.00(0.61~1.62) 0.55
ALT升高 11 2.69(1.54~4.71) <0.001 10 3.04(1.80~5.13) 0.90
AST升高 11 2.89(1.59~5.27) <0.001 10 2.77(1.77~4.34) 0.39
高胆红素血症 12 2.16(1.24~3.75) <0.001 11 1.85(1.19~2.86) 0.10
血小板降低 12 2.62(1.34~5.13) <0.001 11 2.20(1.45~3.33) 0.31
中性粒细胞减少 5 10.88(6.43~18.41) 0.68 5 8.54(2.55~28.57) 0.96
贫血 5 1.69(0.99~2.91) 0.95 5 2.60(0.68~9.91) 0.82
甲状腺功能减退 16 0.96(0.75~1.23) 0.91 15 1.93(1.06~3.52) 0.90
瘙痒 7 1.09(0.70~1.71) 0.84 6 0.86(0.33~2.28) 0.51
腹泻 15 1.06(0.79~1.44) 0.01 14 1.91(1.20~3.03) 0.72
恶心呕吐 11 2.35(1.34~4.10) <0.001 10 5.45(2.51~11.81) 0.35
腹痛 6 5.40(2.77~10.53) <0.001 6 3.60(1.25~10.37) 0.01
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