pd-1 antibody versus best supportive care after chemoradiation in locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Neoplasms

Summary: this trial is aimed to investigate whether adjuvant pd-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.

in this multicenter, randomised controlled, phase 3 trial, patients with stage iii-iva (ajcc/uicc 8th system, except t3-4n0 and t3n1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve pd-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed nasopharyngeal carcinoma. * tumor staged as iii-iva (ajcc 8th, except t3n0-1 or t4n0). * completed protocol-specified curative chemoradiotherapy, including gemcitabine and cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy. * completion of the last radiation dose within 1 to 42 days before randomization * eastern cooperative oncology group performance status ≤1. * adequate marrow function: neutrocyte count≥1.5×10e9/l, hemoglobin ≥90g/l and platelet count ≥100×10e9/l. * alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤2.5×upper limit of normal (uln), and bilirubin ≤ 1.5×uln. * adequate renal function: creatinine clearance rate ≥ 60 ml/min (cockcroft-gault formula). * patients must be informed of the investigational nature of this study and give written informed consent. * women of childbearing potential (wocbp) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. men who are sexually active with wocbp must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. exclusion criteria: * age \> 65 or \< 18. * hepatitis b surface antigen (hbsag) positive and hepatitis b virus dna \>1×10e3 copies/ml or 200iu/ml * hepatitis c virus (hcv) antibody positive * has active autoimmune disease, except type i diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). * has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed. * has a known history of active tb (bacillus tuberculosis) within 1 year; patients with adequately treated active tb over 1 year ago will be allowed. * has a known history of interstitial lung disease. * has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. * is pregnant or breastfeeding. * prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. * has known allergy to large molecule protein products or any compound of camrelizumab. * has a known history of human immunodeficiency virus (hiv) infection. * any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Keywords: pd-1 antibody adjuvant treatment immune checkpoint inhibitors