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替雷利珠单抗联合放疗治疗低危早期结外 NK/T 细胞淋巴瘤(鼻型):一项 II 期研究方案

英文原题:Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol.

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Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol.

PubMed 2023/11/29(内容时间) Future Oncol Q2 · IF 3.1(JCR 2025)

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中文摘要

低危早期结外鼻型NK/T细胞淋巴瘤单纯放疗预后良好,加用化疗未显示生存获益。然而,仍有一部分患者会复发或进展,预后极差,凸显了需要新的治疗策略。有希望的初步研究结果表明,PD-1/PD-L1抑制剂在结外鼻型NK/T细胞淋巴瘤中有效,且毒性特征良好。在此我们描述一项II期研究(CLCG-NKT-2101)的设计,该研究正在评估在低危早期结外鼻型NK/T细胞淋巴瘤患者中,在现行放疗方案基础上加用抗PD-1抗体的安全性和有效性。替雷利珠单抗将以诱导和同步的方式加入放疗。主要终点为诱导免疫治疗后的完全缓解率。临床试验注册:ClinicalTrials.gov(NCT05149170)。

展开英文摘要原文

Low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type has a favorable outcome with radiation therapy alone, and the addition of chemotherapy shows no survival benefit. Nonetheless, a proportion of patients will relapse or progress, with a dismal outcome, highlighting the need for a novel therapeutic strategy. Promising preliminary findings indicate the efficacy of PD-1/PD-L1 inhibitors in extranodal natural killer/T-cell lymphoma, nasal type, with good toxicity profiles.

Here we describe the design of a phase II study (CLCG-NKT-2101), which is evaluating the safety and efficacy of adding anti-PD-1 antibody to the current radiation therapy regimen in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type patients. Tislelizumab will be added in an inductive and concurrent way to radiation therapy. The primary end point will be the complete response rate after induction immunotherapy. Clinical trial registration: ClinicalTrials. gov (NCT05149170).

论文信息

作者
Li JY、Qi SN、Hu C、Liu X、Yang Y、Wu T、Zheng R、Feng XL
单位
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.China
文献类型
临床试验方案
期刊
Future oncology (London, England)2024 Feb
原文标识
PubMed 38018460 · DOI 10.2217/fon-2023-0065