本研究旨在回答的主要问题为： 1. 与 GP 诱导化疗联合安慰剂相比，GP 诱导化疗联合 toripalimab 能否改善 3 年无进展生存期（PFS）？ 2. 两组在诱导治疗后的完全缓解（CR）、3 年总生存期（OS）、局部区域恶化及远处恶化方面有何差异？ 3. 两组之间的安全性有何差异？ 4.
适应症：Nasopharyngeal Carcinoma (NPC)
入组条件
纳入标准
- Voluntarily participates and signs an informed consent form.
- Aged 18-70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Staging of any T, N2-3 or T4N1 (9th AJCC/UICC staging), with no distant metastasis.
- ECOG performance status score of 0-1.
- Hemoglobin (HGB) ≥90 g/L, neutrocyte count≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹ /L.
- Liver function: Alanine aminotransferase (ALT) and 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).
- 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 the 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.
排除标准
- Age \> 70 years or \< 18 years.
- Patients with recurrence or distant metastases.
- Pathologically confirmed nasopharyngeal keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously undergone radiotherapy or systemic chemotherapy.
- Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1000 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 who received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroids will be allowed.
- Has a known history of active bacillus tuberculosis within 1 year; patients with adequately treated active bacillus tuberculosis 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 toripalimab.
- Has a known history of human immunodeficiency virus 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。