程序性细胞死亡蛋白1抑制剂与确定性放疗联合免疫营养支持治疗食管鳞状细胞癌的疗效和安全性：一项II期多中心临床试验
Efficacy and safety of concurrent programmed cell death protein 1 inhibitor and definitive radiotherapy with immunonutrition support in esophageal squamous cell cancer: a phase II multicenter clinical trial.
作者信息
Yuan Yupei, Luo Shihong, Wang Xiaomin, Zheng Zhiyong, Qi Qing, Wang Yunxiao, Chen Meiling, Yang Haihua, Gu Pingjun, Du Qin, Wu Xia, Pan Wenyan, Xu Yuanji, Wang Jianyang
机构信息
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No.17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, P. R. China.
Department of Radiation Oncology, Anyang Tumor Hospital, Anyang, Henan Province, 518116, China.
出版信息
Radiat Oncol. 2025 Apr 18;20(1):58. doi: 10.1186/s13014-025-02604-z.
BACKGROUND
Esophageal cancer is one of the most common malignant tumors, with China accounting for 50% of the world's total incidence. Concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, certain patients possess risk factors that heighten toxicity and reduce their tolerance to cCRT, thereby challenging the feasibility of standard treatment. This study evaluates an alternative therapeutic approach combining programmed cell death protein 1 inhibitor (PD-1 inhibitor), definitive radiotherapy, and immunonutrition support for patients with unresectable non-metastatic esophageal cancer expressing PD-L1 who are intolerant to cCRT.
METHODS
This is a phase II, single-arm, multicenter clinical trial involving patients with histologically confirmed unresectable esophageal squamous cell carcinoma (ESCC), who exhibit positive PD-L1 and are unsuitable for cCRT. Participants will receive a total radiotherapy dose of 50-60 Gy in 25-30 fractions, sintilimab (200 mg every three weeks), alongside, supplemented by enteral nutritional emulsion (600-1600 ml/day). The primary endpoint is the 1-year progression-free survival rate, with secondary endpoints including objective response rate, overall survival and incidence of adverse events.
CONCLUSION
This research has the potential to redefine treatment for inoperable ESCC patients who cannot tolerate conventional therapies. By evaluating a less toxic regimen that combines immunotherapy, radiotherapy, and nutritional support, we aim to determine if this approach can improve both survival rates and quality of life. The synergistic effects of immunonutrition support and PD-1 inhibitor will also be explored.
TRIAL REGISTRATION
NCT06342167.
背景
食管癌是最常见的恶性肿瘤之一，中国的发病率占全球总发病率的50%。基于铂类双药方案的同步放化疗（cCRT）是体能状态良好的不可切除局部晚期食管癌患者的标准治疗方法。然而，某些患者存在风险因素，会增加毒性并降低其对cCRT的耐受性，从而对标准治疗的可行性提出挑战。本研究评估了一种替代治疗方法，该方法将程序性细胞死亡蛋白1抑制剂（PD-1抑制剂）、根治性放疗和免疫营养支持相结合，用于对cCRT不耐受的不可切除非转移性食管癌且表达PD-L1的患者。
方法
这是一项II期单臂多中心临床试验，纳入组织学确诊为不可切除食管鳞状细胞癌（ESCC）、PD-L1呈阳性且不适合cCRT的患者。参与者将接受总量为50-60Gy、分25-30次的放疗，信迪利单抗（每三周200mg），同时补充肠内营养乳剂（每天600-1600ml）。主要终点是1年无进展生存率，次要终点包括客观缓解率、总生存率和不良事件发生率。
结论
本研究有可能重新定义无法耐受传统疗法的不可切除ESCC患者的治疗方法。通过评估一种毒性较小的联合免疫疗法、放疗和营养支持的方案，我们旨在确定这种方法是否能提高生存率和生活质量。还将探索免疫营养支持和PD-1抑制剂的协同作用。
试验注册号
NCT06342167。
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