CLINICAL TRIAL article
Front. Oncol.
Sec. Head and Neck Cancer
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1571776
This article is part of the Research TopicAdvances in Neoadjuvant Therapy for Head and Neck Squamous Cell CarcinomaView all 7 articles
Neoadjuvant toripalimab combined with chemotherapy in locally advanced HNSCC Author
Provisionally accepted
Zhaoyang Wang1Sheng Yang2Dangui Yan1
Ye Zhang3Xiwei Zhang1Fa Zhang1Xiaohui Zhao1Zongmin Zhang1
Shaoyan Liu1
Lin Gui2*
Changming An1*- 1Department of Head and Neck Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
- 2Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
- 3Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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To determine the safety and efficacy of neoadjuvant toripalimab combined chemotherapy in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).This single-arm investigator-initiated trial was conducted at a tertiary cancer hospital in China. The untreated LA-HNSCC patients received two cycles of neoadjuvant TP+toripalimab regimen (paclitaxel 175mg/m2 d1, cisplatin 75mg/m2 d1, Toripalimab 240mg d1, every 3 weeks).Surgery or chemoradiotherapy(CRT) was determined via the patient-doctor consensus. The primary endpoints were the objective response rate (ORR) and safety.The study enrolled a total of 23 patients. All the patients completed the entire treatment courses with an ORR of 78.3% (18/23). Any grades of treatment related adverse events (TRAEs) were reported in 12 patients (52.2%), and 3 patients occurred 3-4 grades TRAEs. No delay for curative treatment was observed. 12 patients underwent radical surgery and 6 patients turned out with pathological complete response (pCR), with a pCR rate of 50%. With a median follow-up of 15 months, 12 surgery patients kept event-free survival, however, 3 out of 11 who received CRT suffered from local recurrence or metastases.Conclusions: Neoadjuvant TP+toripalimab for LA-HNSCC showed high ORR and pCR rates with a good safety profile.
Keywords: Head and neck squamous cell carcinoma (HNSCC), Immunotherapy, Neoadjuvant Therapy, Toripalimab, Safety and efficacy
Received: 06 Feb 2025; Accepted: 24 Apr 2025.
Copyright: © 2025 Wang, Yang, Yan, Zhang, Zhang, Zhang, Zhao, Zhang, Liu, Gui and An. 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:
Lin Gui, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Changming An, Department of Head and Neck Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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