替雷利珠单抗的功效？替雷利珠单抗适应症？

替雷利珠单抗的功效？替雷利珠单抗适应症？替雷利珠单抗是国内临床应用比较广泛的一款 PD‑1 免疫检查点抑制剂，在多种实体瘤当中积累了扎实的临床证据，很多患者和家属在选择免疫方案时，都会关心替雷利珠单抗能够带来哪些实际获益，适合哪一类肿瘤人群 [1,2]。它和传统化疗、靶向药的思路不一样，并不是直接杀伤肿瘤细胞，而是通过解除肿瘤对人体免疫的抑制，唤醒自身的 T 淋巴细胞，依靠自身免疫系统去识别、清除癌细胞；药物分子经过结构改造，降低和巨噬细胞受体的结合，有助于保留抗肿瘤的免疫细胞 [2]。在实际临床使用上，既可以单独用药，也能够和化疗联合使用，覆盖肺癌、消化道肿瘤、肝癌、鼻咽癌等多个实体瘤方向。

1、在肺癌领域的疗效证据

肺癌是替雷利珠单抗研究最为充分的癌种。针对可切除非小细胞肺癌的围手术期方案，RATIONALE‑315 的长期随访数据显示，新辅助化疗加上替雷利珠单抗，再接续术后辅助治疗，能够明显提升主要病理缓解率，同时延长无事件生存期，最终分析也观察到总生存的改善，为适合手术的患者提供了围手术期免疫治疗的选择 [3,4]。对于晚期鳞癌与非鳞非小细胞肺癌，一线联合化疗都可以稳定延长无进展生存，提升肿瘤缓解率；而对于已经接受过治疗的晚期非小细胞肺癌，替雷利珠单抗单药对比多西他赛，能够改善总生存，尤其在 PD‑L1 表达较高的人群当中获益更为突出 [5,6,7]。除此之外，广泛期小细胞肺癌一线化疗搭配替雷利珠单抗维持，同样可以延长患者总生存时间 [8]。

2、消化道实体瘤的临床价值

在食管鳞癌当中，无论一线联合化疗，或是二线单独使用替雷利珠单抗，都可以帮助患者延长生存，而且二线单药相比传统化疗，重度不良反应更少，耐受性更好 [9,10]。针对 HER2 阴性的胃以及胃食管结合部腺癌，一线化疗联合替雷利珠单抗，在全部入组人群以及 PD‑L1 高表达亚组都可以观察到生存获益，长期随访的数据也证实获益可以持续 [11,12]。对于 HER2 阳性胃食管腺癌，在双特异性抗体、化疗基础之上叠加替雷利珠单抗的三联方案，也在临床试验当中展现出潜在的生存优势，不过还需要更多成熟数据支撑 [13,14]。

3、肝癌、鼻咽癌与适用边界

一线不可切除肝细胞癌的 RATIONALE‑301 研究证实，替雷利珠单抗单药对比索拉非尼达到总生存非劣效，客观缓解率更高，重度治疗相关不良反应更少，适合体能、肝功能较好的患者 [1]。复发转移鼻咽癌一线化疗联合替雷利珠单抗，能够显著降低疾病进展风险，获益在不同 PD‑L1 表达人群都可以看到 [15]。当然替雷利珠单抗并不是对所有实体瘤都有效，疗效会和肿瘤类型、分期、PD‑L1 表达、身体基础状况相关，不能盲目使用，需要主治医生结合临床试验证据评估。

替雷利珠单抗的功效？替雷利珠单抗适应症？替雷利珠单抗凭借一系列大型 Ⅲ 期研究，已经在多个实体瘤建立治疗证据，为不少晚期、局部进展甚至可手术的肿瘤患者增加了治疗选项，但它依然属于处方抗肿瘤药物，必须严格遵循适应症和临床规范使用。

参考文献：

[1] Qin S, Kudo M, Meyer T, et al. Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial[J]. JAMA Oncol, 2023, 9(12): 1651-1659. (https://pubmed.ncbi.nlm.nih.gov/37796513/)

[2] Lu S, Wang J, Yu Y, et al. Tislelizumab plus chemotherapy as first-line treatment of locally advanced or metastatic nonsquamous non-small-cell lung cancer (final analysis of RATIONALE-304: a randomized phase III trial)[J]. ESMO Open, 2024, 9(10): 103728. (https://pubmed.ncbi.nlm.nih.gov/39461773/)

[3] Yue D, Wang W, Liu H, et al. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial[J]. Lancet Respir Med, 2025, 13(2): 119-129. (https://pubmed.ncbi.nlm.nih.gov/39581197/)

[4] Wang C, Wang W, Liu H, et al. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial[J]. Ann Oncol, 2026, 37(4): 544-554. (https://pubmed.ncbi.nlm.nih.gov/41344593/)

[5] Wang J, Lu S, Yu X, et al. Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: final analysis of the randomized, phase III RATIONALE-307 trial[J]. ESMO Open, 2024, 9(10): 103727. (https://pubmed.ncbi.nlm.nih.gov/39461775/)

[6] Lu S, Wang J, Yu Y, et al. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial[J]. J Thorac Oncol, 2021, 16(9): 1512-1522. (https://pubmed.ncbi.nlm.nih.gov/34033975/)

[7] Zhou C, Huang D, Fan Y, et al. Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3, Open-Label, Randomized Controlled Trial[J]. J Thorac Oncol, 2023, 18(1): 93-105. (https://pubmed.ncbi.nlm.nih.gov/36184068/)

[8] Cheng Y, Fan Y, Zhao Y, et al. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial[J]. J Thorac Oncol, 2024, 19(7): 1073-1085. (https://pubmed.ncbi.nlm.nih.gov/38460751/)

[9] Xu J, Kato K, Raymond E, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study[J]. Lancet Oncol, 2023, 24(5): 483-495. (https://pubmed.ncbi.nlm.nih.gov/37080222/)

[10] Shen L, Kato K, Kim SB, et al. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study[J]. J Clin Oncol, 2022, 40(26): 3065-3076. (https://pubmed.ncbi.nlm.nih.gov/35442766/)

[11] Qiu MZ, Oh DY, Kato K, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial [J]. BMJ, 2024, 385: e078876. (https://pubmed.ncbi.nlm.nih.gov/38806195/)

[12] Cruz-Correa M, Oh DY, Kato K, et al. Tislelizumab + Chemotherapy in Gastric Cancer: Long-Term RATIONALE-305 Randomized Trial Follow-up[J]. Adv Ther, 2026, 43(1): 165-183. (https://pubmed.ncbi.nlm.nih.gov/41251890/)

[13] Shitara K, Elimova E, Liu T, et al. Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer[J]. N Engl J Med, 2026, 394(20): 2002-2014. (https://pubmed.ncbi.nlm.nih.gov/42202319/)

[14] Tabernero J, Shen L, Elimova E, et al. HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma[J]. Future Oncol, 2022, 18(29): 3255-3266. (https://pubmed.ncbi.nlm.nih.gov/36000541/)

[15] Yang Y, Pan J, Wang H, et al. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309)[J]. Cancer Cell, 2023, 41(6): 1061-1072.e4. (https://pubmed.ncbi.nlm.nih.gov/37207654/)