恶性肿瘤新辅助免疫治疗的现状与挑战

doi:10.3760/cma.j.cn371439-20250513-00006

摘要/Abstract

摘要：

恶性肿瘤已成为全球公共卫生领域的重大挑战，严重威胁人类健康及社会发展。尽管现有临床治疗策略不断进步，整体疗效仍有显著局限。在免疫检查点抑制剂的创新应用及大量临床试验与真实世界证据的支持下，新辅助免疫治疗正引领可切除性肿瘤迈向免疫治疗新时代。然而，随着研究的深入，该领域仍面临诸多亟待解决的关键问题。系统分析新辅助免疫治疗的分子机制、临床试验进展及真实世界应用，有望深度揭示当前治疗瓶颈及未来发展方向。

关键词: 免疫检查点抑制剂, 免疫疗法, 肿瘤, 新辅助治疗

Abstract:

Malignant tumors have become a significant challenge in global public health， posing substantial threats to both human health and societal development. Although current clinical treatment strategies continue to advance， the overall therapeutic effect still has significant limitations. Supported by innovative applications of immune checkpoint inhibitors and substantial evidence from both clinical trials and real-world studies， neoadjuvant immunotherapy is leading resectable tumor management into a new era of immunotherapy. However， ongoing research continues to identify crucial issues that require urgent solutions. Systematic analysis of the molecular mechanisms， clinical trial progress， and real-world applications of neoadjuvant immunotherapy is expected to reveal current therapeutic constraints and future development directions.

Key words: Immune checkpoint inhibitors, Immunotherapy, Neoplasms, Neoadjuvant therapy

赵元, 姚文涛. 恶性肿瘤新辅助免疫治疗的现状与挑战[J]. 国际肿瘤学杂志, 2026, 53(1): 47-52.

Zhao Yuan, Yao Wentao. Current status and challenges of neoadjuvant immunotherapy in malignant tumors[J]. Journal of International Oncology, 2026, 53(1): 47-52.

图/表 1

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瘤种	注册号	期别	治疗方案	疗效指标	3~5级不良事件发生率	参考文献
头颈部鳞状细胞癌	NCT03247712	Ⅰ期	纳武利尤单抗+放疗（15例）	MPR率：86%，pCR率：67%	19%	[20]
非小细胞肺癌	NCT03030131	Ⅱ期	度伐利尤单抗（46例）	MPR率：19%，12个月生存率：89%， 12个月无瘤生存率：78%	无	[9]
非小细胞肺癌	NCT03158129	Ⅱ期	纳武利尤单抗（23例）或纳武利尤单抗+伊匹木单抗（21例）	MPR率：24%比50%， pCR率：10%比38%	13%比10%	[10]
非小细胞肺癌	NCT02998528	Ⅲ期	化疗（176例）或纳武利尤单抗+ 化疗（176例）	中位无事件生存期：20.8个月比 31.6个月，pCR率：2.2%比24.0%	36.9%比33.5%	[13]
非小细胞肺癌	NCT02904954	Ⅱ期	度伐利尤单抗（30例）或度伐利尤单抗+放疗（30例）	MPR率：6.7%比53.3%	17%比20%	[21]
食管鳞状细胞癌	ChiCTR2000037488	Ⅱ期	替雷利珠单抗+化疗（45例）	MPR率：72%，pCR率：50%	42.2%	[18]
胃及胃食管结合部腺癌	NCT04065282	Ⅱ期	信迪利单抗+化疗（36例）	MPR率：47.2%，pCR率：19.4%，1年无瘤生存率：90.3%，1年生存率：94.1%	13.9%	[19]
胃及胃食管结合部腺癌	NCT03631615	Ⅱ期	卡瑞利珠单抗+放疗+化疗（36例）	MPR率：44.4%，pCR率：33.3%，2年无进展生存率：66.9%，2年生存率：76.1%	77.8%	[23]
肝细胞癌	NCT03916627	Ⅱ期	西米普利单抗（21例）	切除肿瘤中坏死面积>70%比例：20%	10%	[11]
肝细胞癌	NCT04297202	Ⅱ期	卡瑞利珠单抗+阿帕替尼（18例）	MPR率：17.6%，pCR率：5.9%， 1年无复发生存率：53.85%	16.7%	[25]