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Short-course PD-1 blockade in locally advanced nasopharyngeal carcinoma: a phase II randomized trial protocol (Tori-013)

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机构: [1]Univ Elect Sci & Technol China, Sichuan Canc Hosp & Inst, Sichuan Clin Res Ctr Canc, Dept Radiat Oncol,Sichuan Canc Ctr, Chengdu, Peoples R China [2]Gen Hosp Western Theater Command, Dept Oncol, Chengdu, Peoples R China [3]Second Peoples Hosp Neijiang, Dept Oncol, Neijiang, Peoples R China [4]Second Peoples Hosp Yibin, Dept Oncol, Yibin, Peoples R China [5]Mianyang 404 Hosp, Dept Oncol, Mianyang, Peoples R China [6]Meishan Canc Hosp, Dept Radiat Oncol, Meishan, Peoples R China [7]Sichuan Friendship Hosp, Dept Oncol, Chengdu, Peoples R China
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关键词: nasopharyngeal carcinoma toripalimab PD-1 inhibitor chemoradiotherapy efficacy and safety

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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

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大类 | 2 区 医学
小类 | 2 区 免疫学
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大类 | 2 区 医学
小类 | 2 区 免疫学
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Q1 IMMUNOLOGY
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Q1 IMMUNOLOGY

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第一作者机构: [1]Univ Elect Sci & Technol China, Sichuan Canc Hosp & Inst, Sichuan Clin Res Ctr Canc, Dept Radiat Oncol,Sichuan Canc Ctr, Chengdu, Peoples R China
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