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已发表论文
非流行地区局部晚期鼻咽癌的新辅助化学免疫治疗：一项单臂 2 期临床试验
Authors Zhou L, Tao Z, Zhou Y, Yang L, Zhang Y, He J, Sun B, Wang R, Yang J, Gao J
Received 7 August 2025
Accepted for publication 23 December 2025
Published 15 January 2026 Volume 2026:18 559229
DOI https://doi.org/10.2147/CMAR.S559229
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Sanjeev K. Srivastava
Lingran Zhou, Zhenchao Tao, Yan Zhou, Liping Yang, Yangyang Zhang, Jian He, Bin Sun, Ru Wang, Jing Yang, Jin Gao
Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
Correspondence: Jin Gao, Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China, Email gjfl2011@126.com
Background and Purpose: Nasopharyngeal carcinoma (NPC) is a malignancy with distinct geographical distribution and is rare in non-endemic regions. Despite significant improvements in NPC survival through chemoradiotherapy, recurrence and metastasis remain major clinical challenges, particularly in non-endemic areas where data on neoadjuvant immunochemotherapy are scarce. This study aimed to address this gap by evaluating the antitumor activity and safety of neoadjuvant gemcitabine–cisplatin plus camrelizumab in patients with locally advanced NPC in non-endemic regions.
Materials and Methods: In this single-center, single-arm, phase 2 trial, patients with stage III–IVA NPC received chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8, plus cisplatin 80 mg/m2 on day 1) and camrelizumab 200 mg on day 1 for three cycles, followed by radiotherapy. Primary endpoints were objective response rate (ORR). Secondary endpoints included disease-free survival (DFS), overall survival (OS), and biomarker correlations in addition to the primary ORR.
Results: Thirty-eight patients were enrolled and thirty-three completed three cycles of the neoadjuvant therapy, resulting in an ORR of 89.4% (34/38). The median follow-up duration was 18.5 months, and the 12-month disease-free survival rate was 94.7% (34/36). Six patients encountered grade 3 adverse effects: Two with nausea/vomiting, two with thrombocytopenia, one with leukopenia, and one with immune-related hepatitis. No grade 4 treatment-related events or deaths occurred.
Conclusion: Neoadjuvant camrelizumab combined with chemotherapy demonstrated promising antitumor activity and acceptable safety in locally advanced NPC patients from non-endemic regions. However, further randomized studies are needed to confirm these findings and assess long-term survival benefits.
Keywords: neoadjuvant chemoimmunotherapy, PD-1 inhibitor, camrelizumab, nasopharyngeal carcinoma, radiotherapy
Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
Correspondence: Jin Gao, Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China, Email gjfl2011@126.com
Background and Purpose: Nasopharyngeal carcinoma (NPC) is a malignancy with distinct geographical distribution and is rare in non-endemic regions. Despite significant improvements in NPC survival through chemoradiotherapy, recurrence and metastasis remain major clinical challenges, particularly in non-endemic areas where data on neoadjuvant immunochemotherapy are scarce. This study aimed to address this gap by evaluating the antitumor activity and safety of neoadjuvant gemcitabine–cisplatin plus camrelizumab in patients with locally advanced NPC in non-endemic regions.
Materials and Methods: In this single-center, single-arm, phase 2 trial, patients with stage III–IVA NPC received chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8, plus cisplatin 80 mg/m2 on day 1) and camrelizumab 200 mg on day 1 for three cycles, followed by radiotherapy. Primary endpoints were objective response rate (ORR). Secondary endpoints included disease-free survival (DFS), overall survival (OS), and biomarker correlations in addition to the primary ORR.
Results: Thirty-eight patients were enrolled and thirty-three completed three cycles of the neoadjuvant therapy, resulting in an ORR of 89.4% (34/38). The median follow-up duration was 18.5 months, and the 12-month disease-free survival rate was 94.7% (34/36). Six patients encountered grade 3 adverse effects: Two with nausea/vomiting, two with thrombocytopenia, one with leukopenia, and one with immune-related hepatitis. No grade 4 treatment-related events or deaths occurred.
Conclusion: Neoadjuvant camrelizumab combined with chemotherapy demonstrated promising antitumor activity and acceptable safety in locally advanced NPC patients from non-endemic regions. However, further randomized studies are needed to confirm these findings and assess long-term survival benefits.
Keywords: neoadjuvant chemoimmunotherapy, PD-1 inhibitor, camrelizumab, nasopharyngeal carcinoma, radiotherapy