Camrelizumab-based induction chemoimmunotherapy in locally advanced stage hypopharyngeal carcinoma: phase II clinical trial

Hongli Gong, Shu Tian, Hao Ding, Lei Tao, Li Wang, Jie Wang, Tian Wang, Xiaohui Yuan, Yu Heng, Ming Zhang, Yong Shi, Chengzhi Xu, Chunping Wu, Shengzi Wang () and Liang Zhou ()
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Hongli Gong: Fudan University
Shu Tian: Fudan University
Hao Ding: Fudan University
Lei Tao: Fudan University
Li Wang: Fudan University
Jie Wang: Fudan University
Tian Wang: Fudan University
Xiaohui Yuan: Fudan University
Yu Heng: Fudan University
Ming Zhang: Fudan University
Yong Shi: Fudan University
Chengzhi Xu: Fudan University
Chunping Wu: Fudan University
Shengzi Wang: Fudan University
Liang Zhou: Fudan University

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract This phase II trial aimed to determine the efficacy and safety of induction chemoimmunotherapy of camrelizumab plus modified TPF in locally advanced hypopharyngeal squamous cell carcinoma (LA HSCC) (NCT04156698). The primary endpoint was objective response rate (ORR), and secondary endpoints were 3-year overall survival (OS), progression-free survival (PFS), larynx preservation rate (LPR), and metastasis-free survival (MFS). Patients (cT3-4aN0-2M0), regardless of sex, received induction chemoimmunotherapy for three cycles: camrelizumab 200 mg d1, docetaxel 75 mg/m2 d1, cisplatin 25 mg/m2 d1-3, and capecitabine 800 mg/m2 bid d1-14, q21d. Patients were assigned to radioimmunotherapy if they had a complete or partial response, those with stable or progressive disease underwent surgery and adjuvant (chemo)radiotherapy. Camrelizumab was maintained post-radioimmunotherapy. Fifty-one patients were enrolled with a median follow-up duration of 23.7 months. After induction therapy, the ORR was 82.4% (42/51), meeting the prespecified endpoint. Grade 3/4 adverse events occurred in 26 patients, and no treatment-related death occurred. As three-year outcomes were immature, two-year OS, PFS and LPR were reported. As no distant metastatic event had occurred, MFS was not reported here. The two-year OS, PFS, and LPR rates were 83.0%, 77.1%, and 70.0%, respectively. The induction chemoimmunotherapy of camrelizumab plus TPF showed a high ORR rate with an acceptable safety profile in LA HSCC.

Date: 2024
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DOI: 10.1038/s41467-024-49121-3

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