| Summary: | Abstract Purpose Management of locoregionally recurrent nasopharyngeal carcinoma (LR NPC) is difficult. Although carbon‐ion radiation therapy (CIRT) could substantially improve the overall survival (OS) of those patients, around 40% of the patients may still develop local failure. Further improvement of the disease control is necessary. Immunotherapy, such as immune checkpoint inhibitors (ICIs) becomes a promising antitumor treatment. The role of ICIs was proved in head and neck cancers including recurrent/metastatic NPC. Preclinical studies indicated potential synergistic effects between radiation therapy and ICIs. Therefore, we conduct a randomized phase 2 trial to evaluate the efficacy and safety of camrelizumab, an anti‐PD‐1 monoclonal antibody, along with CIRT in patients with LR NPC. Methods Patients will be randomly assigned at 1:1 to receive either standard CIRT with 63 Gy (relatively biological effectiveness, [RBE]) in 21 fractions, or standard CIRT plus concurrent camrelizumab. Camrelizumab will be administered intravenously with a dose of 200 mg, every 2 week, for a maximum of 1 year. We estimate addition of camrelizumab will improve the 2‐year progression‐free survival (PFS) from 45% to 60%. A total of 146 patients (with a 5% lost to follow‐up rate) is required to yield a type I error of 0.2, and a power of 0.8. Results and Conclusion The results of the trial may shed insights on the combined therapy with ICIs and CIRT.
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