Neoadjuvant immunotherapy with or without chemotherapy in locally advanced oral squamous cell carcinoma: Randomized, two-arm, phase 2 trial.

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Tác giả: Gai-Li Chen, Gang Chen, Xiao-Xia Cheng, Qiu-Yun Fu, Hong-Yun Gong, Jun Jia, Bo Li, Jing Li, Bing Liu, Hai-Ming Liu, Yu-Tong Liu, Zhe Shao, Xin-Xin Wang, Xue-Peng Xiong, Zi-Li Yu, Jia-Li Zhang, Wei Zhang, Ya-Hua Zhong

Ngôn ngữ: eng

Ký hiệu phân loại: 950.25 1405—1480

Thông tin xuất bản: United States : Cell reports. Medicine , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 679281

Patients with locally advanced oral squamous cell carcinoma (OSCC) have poor outcomes with standard care. Neoadjuvant therapy is shown to be effective for these patients. In the randomized, two-arm, phase 2, non-comparative trial, we investigate the efficacy and safety of the neoadjuvant programmed cell death 1 (PD-1) inhibitor camrelizumab with or without docetaxel-cisplatin-5-fluorouracil (TPF) chemotherapy in patients with resectable locally advanced OSCC. Patients with stage III-IVA OSCC receive neoadjuvant therapy with three cycles of camrelizumab (arm Cam) with or without two cycles of TPF chemotherapy (arm Cam+TPF), followed by surgery and adjuvant therapy. Major pathological response (MPR) is achieved in both arm Cam (5/34, 14.7%) and arm Cam+TPF (26/34, 76.4%). With a median follow-up of 32 months, the 2-year event-free survival (EFS) rate of arm Cam and Cam+TPF is 52.9% and 91.2%, respectively. This work demonstrates feasibility and safety for immunochemotherapy in the neoadjuvant setting for OSCC. This study was registered at ClinicalTrials.gov (NCT04649476).
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