STUDY PROTOCOL article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1633243
Short-Course PD-1 Blockade in Locally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Trial Protocol (Tori-013)
Provisionally accepted
Hongyuan Jia1
Junchao Wang1
Ling Zhang2Haijun Li3Yalei Du4Wenjuan Luo5Zou Wei6Xiaohui Wang7Weidong Wang1*- 1Sichuan Cancer Hospital, Chengdu, China
- 2Chinese People's Liberation Army Western Theater General Hospital, Chengdu, China
- 3The Second People’s Hospital of Neijiang, Neijiang, China
- 4The Second People's Hospital of Yibin City, Yibin, China
- 5Mianyang 404 Hospital, Mianyang, China
- 6Meishan Cancer Hospital, Meishan, China
- 7Sichuan Friendship hospital, Chengdu, China
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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
Keywords: nasopharyngeal carcinoma, Toripalimab, PD-1 inhibitor, Chemoradiotherapy, efficacy and safety
Received: 22 May 2025; Accepted: 01 Aug 2025.
Copyright: © 2025 Jia, Wang, Zhang, Li, Du, Luo, Wei, Wang and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Weidong Wang, Sichuan Cancer Hospital, Chengdu, China
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