Jia Hongyuan, Wang Junchao, Zhang Ling, Li Haijun, Du Yalei, Luo Wenjuan, Wei Zou, Wang Xiaohui, Wang Weidong
Department of Radiation Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China.
Department of Oncology, The General Hospital of Western Theater Command, Chengdu, China.
Front Immunol. 2025 Aug 18;16:1633243. doi: 10.3389/fimmu.2025.1633243. eCollection 2025.
While immunotherapy has demonstrated encouraging efficacy in locally advanced nasopharyngeal carcinoma (LANPC), the optimal combination modalities and treatment duration remain undetermined. In the present study, we developed a clinical trial protocol to evaluate shortened period of immunotherapy could enhance the efficacy of LANPC. This open-label, randomized, single-blind, multicenter phase II trial (Tori-013) investigates the efficacy and safety of toripalimab (anti-PD-1 monoclonal antibody) combined with induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) in patients with stage III/IVa nasopharyngeal carcinoma (NPC). Eligible participants (estimated n=154) are randomized 1:1 to receive either IC (gemcitabine + cisplatin) plus CCRT (cisplatin + radiotherapy ≥ 70 Gy) with toripalimab (240 mg, Q3W) or placebo. Toripalimab/placebo is administered during IC and CCRT phases, followed by two additional cycles post-radiotherapy. The primary endpoint is 3-year progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), Epstein-Barr virus (EBV) DNA dynamics, lymphocyte subset changes, and safety. Safety assessments focus on immune-related adverse events (irAEs) graded by CTCAE v5.0. Approved by the Ethics Committee of Sichuan Cancer Hospital (KY-2021-113) and registered (ChiCTR2200055494), this trial aims to establish a novel, streamlined immunochemoradiotherapy strategy for locally advanced NPC, potentially enhancing efficacy while maintaining tolerability.
虽然免疫疗法在局部晚期鼻咽癌（LANPC）中已显示出令人鼓舞的疗效，但最佳联合方式和治疗持续时间仍未确定。在本研究中，我们制定了一项临床试验方案，以评估缩短免疫治疗周期是否能提高LANPC的疗效。这项开放标签、随机、单盲、多中心II期试验（Tori-013）研究了托瑞帕利单抗（抗PD-1单克隆抗体）联合诱导化疗（IC）继以同步放化疗（CCRT）用于III/IVa期鼻咽癌（NPC）患者的疗效和安全性。符合条件的参与者（估计n = 154）按1:1随机分组，接受IC（吉西他滨+顺铂）加CCRT（顺铂+放疗≥70 Gy）联合托瑞帕利单抗（240 mg，每3周一次）或安慰剂。托瑞帕利单抗/安慰剂在IC和CCRT阶段给药，放疗后再追加两个周期。主要终点是3年无进展生存期（PFS），次要终点包括总生存期（OS）、客观缓解率（ORR）、爱泼斯坦-巴尔病毒（EBV）DNA动态变化、淋巴细胞亚群变化和安全性。安全性评估重点关注根据CTCAE v5.0分级的免疫相关不良事件（irAEs）。本试验经四川省肿瘤医院伦理委员会批准（KY-2021-113）并已注册（ChiCTR2200055494），旨在为局部晚期NPC建立一种新的、简化的免疫放化疗策略，可能在维持耐受性的同时提高疗效。
