{
  "abstract": "Abstract Objective To assess treatment with camrelizumab (a programmed death 1 inhibitor) in addition to concurrent chemoradiotherapy and as a maintenance treatment in patients with high risk nasopharyngeal carcinoma.Design Multicentre, randomised, open label, phase 3 trial.Setting Seven hospitals in China between 18 August 2020 and 21 June 2022.Participants Adults aged 18-70 years with newly diagnosed high risk nasopharyngeal carcinoma after three cycles of induction chemotherapy with gemcitabine and cisplatin (stage 4a, stage 2-3 with stable or progressive disease, or detectable Epstein-Barr virus DNA).Interventions Patients were randomly assigned (1:1) to receive combination chemoradiotherapy based on cisplatin (standard treatment group) or standard treatment with 19 cycles of intravenous camrelizumab (200 mg) once every three weeks (radiotherapy plus two concurrent cycles and 17 adjuvant cycles; camrelizumab group).Main outcome measures The primary endpoint in the intention-to-treat group was progression-free survival, defined as the time from randomisation to disease recurrence (locoregional or distant) or death from any cause. Secondary endpoints included safety and overall survival.Results 390 patients were enrolled and randomly assigned to the camrelizumab group (n=194) or the standard treatment group (n=196). At median follow-up of 39.9 months (interquartile range 36.8-43.4 months), progression-free survival was higher in the camrelizumab group than the standard treatment group (36 months: 83.4%, 95% confidence interval 78.3% to 88.8% v 71.3%, 65.2% to 77.9%; stratified hazard ratio 0.51, 95% confidence interval 0.34 to 0.77, P=0.001). The incidence of acute and late adverse events (grade 3 or 4) was 50.5% and 3.2% in the camrelizumab group compared with 48.7% and 3.7% in the standard treatment group. Immunological adverse events (grade 3 or 4) occurred in 19 patients (10.2%) in the camrelizumab group.Conclusion The addition of camrelizumab to concurrent chemoradiotherapy and as a maintenance treatment improved progression-free survival among patients with high risk nasopharyngeal carcinoma after induction chemotherapy.Trial registration ClinicalTrials.gov NCT04453826",
  "authors": [
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Rui You"
    },
    {
      "affiliations": [
        "Nasopharyngeal Head and Neck Radiotherapy Department, Zhongshan City People’s Hospital, Zhongshan, China"
      ],
      "name": "Gui-Qiong Xu"
    },
    {
      "affiliations": [
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Xi Ding"
    },
    {
      "affiliations": [
        "Department of Radiation Oncology, Wuzhou Red Cross Hospital, Wuzhou, China"
      ],
      "name": "Jin-Hui Liang"
    },
    {
      "affiliations": [
        "Cancer Center, Dongguan Key Laboratory of Precision Diagnosis and Treatment for Tumors, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), Dongguan, China",
        "Department of Head and Neck Cancer, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Zhi-Gang Liu"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Xiong Zou"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "You-Ping Liu"
    },
    {
      "affiliations": [
        "Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China"
      ],
      "name": "Guang-Yuan Hu"
    },
    {
      "affiliations": [
        "Department of Oncology, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China"
      ],
      "name": "Yi-Min Liu"
    },
    {
      "affiliations": [
        "Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China"
      ],
      "name": "Chong-Yang Duan"
    },
    {
      "affiliations": [
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "Department of Medical Imaging, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Li-Zhi Liu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "Department of Medical Imaging, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Wei-Jing Zhang"
    },
    {
      "affiliations": [
        "ENT Department, the First Hospital of Nanchang City, Nanchang, China"
      ],
      "name": "Qian Liu"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Hui-Feng Li"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Yan-Feng Ouyang"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Xiao-Tong Duan"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Qin Wang"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Lan Peng"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Jiong-Lin Liang"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Zheng-Kai Feng"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Zi-Han Qin"
    },
    {
      "affiliations": [
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Xiao Liu"
    },
    {
      "affiliations": [
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Zhi-Kun He"
    },
    {
      "affiliations": [
        "Department of Radiation Oncology, Wuzhou Red Cross Hospital, Wuzhou, China"
      ],
      "name": "Bin Zhang"
    },
    {
      "affiliations": [
        "Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China"
      ],
      "name": "Guo-Xian Long"
    },
    {
      "affiliations": [
        "Department of Oncology, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China"
      ],
      "name": "Yan-Hui Jiang"
    },
    {
      "affiliations": [
        "Nasopharyngeal Head and Neck Radiotherapy Department, Zhongshan City People’s Hospital, Zhongshan, China"
      ],
      "name": "Feng Lei"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Pei-Yu Huang"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China"
      ],
      "name": "Yi-Jun Hua"
    },
    {
      "affiliations": [
        "Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China",
        "Nasopharyngeal Cancer Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Guangdong Engineering Research Center of Nasopharyngeal Carcinoma Early Screening and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China",
        "Zhuhai Key Laboratory of Cancer Prevention and Treatment, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China"
      ],
      "name": "Ming-Yuan Chen"
    }
  ],
  "title": "Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial",
  "uid": "e63cab95-99d7-52e1-b42c-793a95f9c7ba"
}