Neoadjuvant Immunotherapy with or Without Chemotherapy in Locally Advanced Oral Squamous Cell Carcinoma: Randomized, Two-arm, Phase 2 Trial

Overview

Journal Cell Rep Med

Publisher Cell Press

Date 2025 Jan 31

PMID 39889711

Authors

Hai-Ming Liu

Xue-Peng Xiong

Zi-Li Yu

Zhe Shao

Gai-Li Chen

Yu-Tong Liu

Xin-Xin Wang

Qiu-Yun Fu

Xiao-Xia Cheng

Jing Li

Jia-Li Zhang

Bo Li

Hong-Yun Gong

Ya-Hua Zhong

Wei Zhang

Jun Jia

Bing Liu

Gang Chen

Affiliations

Soon will be listed here.

Abstract

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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