Toripalimab plus capecitabine in the treatment of patients with residual nasopharyngeal carcinoma: a single-arm phase 2 trial

Xun Cao, Hao-Yang Huang, Chi-Xiong Liang, Zhuo-Chen Lin, Jia-Yu Zhou, Xi Chen, Ying-Ying Huang, Ze-Jiang Zhan, Liang-Ru Ke, Lu-Jun Han, Wei-Xiong Xia, Lin-Quan Tang, Shan-Shan Guo, Hu Liang, Xiang Guo and Xing Lv ()
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Xun Cao: Sun Yat-sen University Cancer Centre
Hao-Yang Huang: Sun Yat-sen University Cancer Centre
Chi-Xiong Liang: Sun Yat-sen University Cancer Centre
Zhuo-Chen Lin: The First Affiliated Hospital of Sun Yat-sen University
Jia-Yu Zhou: Sun Yat-sen University Cancer Centre
Xi Chen: Sun Yat-sen University Cancer Centre
Ying-Ying Huang: Sun Yat-sen University Cancer Centre
Ze-Jiang Zhan: Sun Yat-sen University Cancer Centre
Liang-Ru Ke: Sun Yat-sen University Cancer Centre
Lu-Jun Han: Sun Yat-sen University Cancer Centre
Wei-Xiong Xia: Sun Yat-sen University Cancer Centre
Lin-Quan Tang: Sun Yat-sen University Cancer Centre
Shan-Shan Guo: Sun Yat-sen University Cancer Centre
Hu Liang: Sun Yat-sen University Cancer Centre
Xiang Guo: Sun Yat-sen University Cancer Centre
Xing Lv: Sun Yat-sen University Cancer Centre

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

Abstract: Abstract Patients with residual nasopharyngeal carcinoma after receiving definitive treatment have poor prognoses. Although immune checkpoint therapies have achieved breakthroughs for treating recurrent and metastatic nasopharyngeal carcinoma, none of these strategies have been assessed for treating residual nasopharyngeal carcinoma. In this single-arm, phase 2 trial, we aimed to evaluate the antitumor efficacy and safety of toripalimab (anti-PD1 antibody) plus capecitabine in patients with residual nasopharyngeal carcinoma after definitive treatment (ChiCTR1900023710). Primary endpoint of this trial was the objective response rate assessed according to RECIST (version 1.1). Secondary endpoints included complete response rate, disease control rate, duration of response, progression-free survival, safety profile, and treatment compliance. Between June 1, 2020, and May 31, 2021, 23 patients were recruited and received six cycles of toripalimab plus capecitabine every 3 weeks. In efficacy analyses, 13 patients (56.5%) had complete response, and 9 patients (39.1%) had partial response, with an objective response rate of 95.7% (95% CI 78.1-99.9). The trial met its prespecified primary endpoint. In safety analyses, 21 of (91.3%) 23 patients had treatment-related adverse events. The most frequently reported adverse event was hand-foot syndrome (11 patients [47.8%]). The most common grade 3 adverse event was hand-foot syndrome (two patients [8.7%]). No grades 4-5 treatment-related adverse events were recorded. This phase 2 trial shows that combining toripalimab with capecitabine has promising antitumour activity and a manageable safety profile for patients with residual nasopharyngeal carcinoma.

Date: 2024
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DOI: 10.1038/s41467-024-45276-1

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