问题特瑞普利单抗功效作用?特瑞普利单抗最新适应症?

特瑞普利单抗功效作用?特瑞普利单抗最新适应症?特瑞普利单抗是我国自主研发的PD-1免疫检查点抑制剂,如今已经在多种实体肿瘤的临床治疗中得到应用,很多肿瘤患者和家属在了解免疫治疗方案时,都会重点关注特瑞普利单抗的作用与功效。和传统放化疗直接杀伤肿瘤细胞的模式不同,这款药物是通过调动患者自身的免疫系统来对抗肿瘤,近年来大量临床研究也持续补充它在不同癌种里的治疗证据[1,2]。
1、特瑞普利单抗的基本作用原理
人体T细胞表面存在PD-1受体,肿瘤细胞会借助PD-L1与PD-1结合,抑制免疫细胞活性,实现免疫逃逸。特瑞普利单抗可以阻断PD-1和配体的结合,解除肿瘤对免疫系统的抑制,让体内的T细胞重新活化、增殖,进而识别并清除肿瘤细胞[2]。它既可以单独使用,也常和化疗、靶向、ADC药物联合使用,适配不同癌种、不同分期的实体瘤治疗方案。
2、在肺癌中的临床应用效果
在可切除非小细胞肺癌围手术期治疗中,NeotorchⅢ期研究证实,特瑞普利单抗联合术前术后化疗,能够明显提升主要病理缓解率与病理完全缓解率,降低疾病复发风险,改善无事件生存期[1,3]。晚期无驱动基因突变非小细胞肺癌的CHOICE-01研究显示,化疗基础上加用特瑞普利单抗,可以延长患者无进展生存期和总生存期;EXTENTORCH研究也支持,特瑞普利单抗联合化疗用于广泛期小细胞肺癌一线治疗,可带来生存获益[2,4]。
3、在鼻咽癌、消化道肿瘤等癌种中的疗效证据
JUPITER-02研究奠定了特瑞普利单抗联合GP化疗作为复发转移性鼻咽癌一线方案的地位,能够持续延长患者的无进展生存和总生存时间[5,6]。在晚期食管鳞癌一线治疗中,JUPITER-06研究同样观察到生存获益[7]。除此之外,它在尿路上皮癌、肾细胞癌、三阴性乳腺癌、胆管癌等实体瘤中也有相应的临床试验探索,其中三阴性乳腺癌获益人群主要集中在PD-L1阳性患者群体[8,9,10,11]。
4、疗效的局限性与生物标志物参考
需要客观看待,特瑞普利单抗并不是对所有肿瘤患者都有效。PD-L1表达、肿瘤突变负荷、肿瘤免疫微环境等标志物有一定参考价值,但目前多数标志物还处于探索阶段,不能作为精准筛选获益患者的唯一标准[9,12]。医生需要结合癌种、分期、基因检测结果、身体状态综合判断是否适合该方案。
特瑞普利单抗功效作用?特瑞普利单抗最新适应症?特瑞普利单抗为肺癌、鼻咽癌等多种实体瘤提供了重要的免疫治疗选择,但临床使用必须严格遵循适应症和临床试验证据,个体化评估获益风险。
参考文献:
[1] Lu S, Zhang W, Wu L, et al. Perioperative Toripalimab Plus Chemotherapy for Patients With Resectable Non-Small Cell Lung Cancer: The Neotorch Randomized Clinical Trial [J]. JAMA, 2024, 331 (3): 201-211. https://pubmed.ncbi.nlm.nih.gov/38227033/
[2] Wang Z, Wu L, Li B, et al. Toripalimab Plus Chemotherapy for Patients With Treatment-Naive Advanced Non-Small-Cell Lung Cancer: A Multicenter Randomized Phase III Trial (CHOICE-01)[J]. J Clin Oncol, 2023, 41(3): 651-663. https://pubmed.ncbi.nlm.nih.gov/36206498/
[3] Fang W, Wang Y, Wang W, et al. Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial[J]. JAMA Surg, 2026, 161(9): 881-889. https://pubmed.ncbi.nlm.nih.gov/42455561/
[4] Cheng Y, Zhang W, Wu L, et al. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial[J]. JAMA Oncol, 2025, 11(1): 16-25. https://pubmed.ncbi.nlm.nih.gov/39541202/
[5] Mai HQ, Chen QY, Chen D, et al. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial[J]. JAMA, 2023, 330(20): 1961-1970. https://pubmed.ncbi.nlm.nih.gov/38015220/
[6] Mai HQ, Chen QY, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial[J]. Nat Med, 2021, 27(9): 1536-1543. https://pubmed.ncbi.nlm.nih.gov/34341578/
[7] Wang ZX, Cui C, Yao J, et al. Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial[J]. Cancer Cell, 2022, 40(3): 277-288.e3. https://pubmed.ncbi.nlm.nih.gov/35245446/
[8] Sheng X, Zeng G, Zhang C, et al. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer[J]. N Engl J Med, 2025, 393(23): 2324-2337. https://pubmed.ncbi.nlm.nih.gov/41124210/
[9] Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial[J]. Nat Med, 2024, 30(1): 249-256. https://pubmed.ncbi.nlm.nih.gov/38191615/
[10] Shi GM, Huang XY, Wu D, et al. Toripalimab combined with lenvatinib and GEMOX is a promising regimen as first-line treatment for advanced intrahepatic cholangiocarcinoma: a single-center, single-arm, phase 2 study[J]. Signal Transduct Target Ther, 2023, 8(1): 106. https://pubmed.ncbi.nlm.nih.gov/36928584/
[11] Yan XQ, Ye MJ, Zou Q, et al. Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study[J]. Ann Oncol, 2024, 35(2): 190-199. https://pubmed.ncbi.nlm.nih.gov/37872020/
[12] Cheng K, Li X, Lv W, et al. Spatial interactions of immune cells as potential predictors to efficacy of toripalimab plus chemotherapy in locally advanced or metastatic pancreatic ductal adenocarcinoma: a phase Ib/II trial[J]. Signal Transduct Target Ther, 2024, 9(1): 321. https://pubmed.ncbi.nlm.nih.gov/39582060/






















