Lan Tianhang, Zhu Yingying, Zhong Wenlong, Tan Qihong, Lin Tianxin, Huang Jian, He Wang
Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 107 Yan Jiang West Road, Guangzhou, Guangdong, 510120, China.
Clinical Research Design Division, Clinical Research Center, Sun Yat- sen Memorial Hospital, Sun Yat-sen University, Guangdong, 510120, China.
BMC Cancer. 2025 May 13;25(1):868. doi: 10.1186/s12885-025-14234-5.
Muscle invasive bladder cancer (MIBC) is a malignancy with high recurrence and metastasis rate. Radical cystectomy and lymph node dissection are the current standard cares for MIBC. The demand for bladder preservation in MIBC patients is growing daily; however, the recognized trimodal bladder-sparing regimen has been shown to have substantial radiation damage and inconsistent efficacy in numerous investigations. In order to address these issues, a secure and efficient bladder preservation program is desperately needed. Therefore, a novel bladder-sparing modality that employing antibody-drug conjugates and immune checkpoint inhibitors combined with pelvic lymph node dissection is worth investigating further in this setting.
In this multicenter, single-arm clinical trial, subjects who were diagnosed with muscle-invasive bladder cancer with human epidermal growth factor receptor-2 expression ≥ 2 + will be enrolled. Eligible subjects will receive 12 cycles Disitamab Vedotin combined with Toripalimab treatment and pelvic lymph node dissection after completed transurethral bladder tumor resection, efficacy evaluation would be performed in all of them, patients who achieved clinical complete response will receive 1-year bladder-sparing therapy with Toripalimab immune maintenance treatment. The primary endpoint is 2-year Bladder-intact disease-free survival, and the secondary endpoints include clinical complete response rate, over survival, quality of life, safety and exploratory objectives that biomarkers will be evaluated.
Disitamab Vedotin combined with Toripalimab therapy and pelvic lymph node dissection is a promising bladder-sparing treatment option that has the potential to improve the rate of bladder-intact disease-free survival and may become a novel modality of bladder-sparing regimen if the study endpoints are met.
This study was registered at Chinese Clinical Trial Registry (ldentifer: ChiCTR2400081555) on March 5, 2024.
肌层浸润性膀胱癌（MIBC）是一种复发和转移率较高的恶性肿瘤。根治性膀胱切除术和淋巴结清扫术是目前治疗MIBC的标准方法。MIBC患者对膀胱保留的需求日益增加；然而，在众多研究中，公认的三联保膀胱方案已显示出严重的放射损伤且疗效不一致。为了解决这些问题，迫切需要一个安全有效的膀胱保留方案。因此，一种采用抗体药物偶联物和免疫检查点抑制剂联合盆腔淋巴结清扫的新型保膀胱模式值得在此背景下进一步研究。
在这项多中心、单臂临床试验中，将纳入被诊断为肌层浸润性膀胱癌且人表皮生长因子受体-2表达≥2+的受试者。符合条件的受试者在完成经尿道膀胱肿瘤切除术后，将接受12个周期的迪西他单抗维泊妥珠单抗联合托瑞帕利单抗治疗及盆腔淋巴结清扫，所有受试者均进行疗效评估，达到临床完全缓解的患者将接受为期1年的托瑞帕利单抗免疫维持治疗的保膀胱治疗。主要终点是2年膀胱完整无病生存率，次要终点包括临床完全缓解率、总生存期、生活质量、安全性以及将评估生物标志物的探索性目标。
迪西他单抗维泊妥珠单抗联合托瑞帕利单抗治疗及盆腔淋巴结清扫是一种有前景的保膀胱治疗选择，有可能提高膀胱完整无病生存率，如果达到研究终点，可能成为一种新型的保膀胱方案。
本研究于2024年3月5日在中国临床试验注册中心注册（标识符：ChiCTR2400081555）。
