University of Pittsburgh Medical Center, Pittsburgh, PA 15232, USA.
University of Birmingham, Birmingham, B15 2TT, UK.
Future Oncol. 2024 Apr;20(12):739-748. doi: 10.2217/fon-2023-0774. Epub 2024 Jan 10.
There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.
对于接受手术治疗的、高风险的、不能使用顺铂的局部晚期头颈部鳞状细胞癌（LA SCCHN）患者，存在着显著的未满足的需求和治疗选择的缺乏。Xevinapant 是一种首创的、有效的口服小分子 IAP 抑制剂，在临床和临床前研究中被认为可以恢复癌细胞对化疗和放疗的敏感性。我们描述了 XRay Vision（NCT05386550）的设计，这是一项国际性、随机、双盲、III 期研究。大约 700 名接受手术治疗的、高风险的、不能使用顺铂的 LA SCCHN 患者将以 1:1 的比例随机分配，接受 6 个周期的 xevinapant 或安慰剂，与前 3 个周期的放疗联合使用。主要终点是无病生存期，次要终点包括总生存期、健康相关生活质量和安全性。
