OncoMatch/Clinical Trials/NCT05628922
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
Is NCT05628922 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab for nasopharyngeal cancer.
Treatment: Toripalimab — Nasopharyngeal carcinoma is biologically different from traditional head and neck squamous cell carcinoma. The mainstay treatment for locally advanced nasopharyngeal carcinoma is cisplatin-based concurrent chemoradiation. Recent phase III randomized control trials have demonstrated that induction chemotherapy plus concurrent chemoradiation further improved progression-free survival. However, not every patient has good response to induction chemotherapy. Evidence has accumulated that those with poor response to induction chemotherapy, or those with detectable Epstein-Barr Virus (EBV) DNA post induction chemotherapy, correlated with poorer progression-free survival. Huang CL et al. (Int J Radiat Oncol Bio Phys. 2019) reported that plasma EBV DNA load at completion of induction chemotherapy was an independent and earlier predictor for progression-free survival and overall survival in locally advanced nasopharyngeal carcinoma. Lv J et al. (Nat Commun. 2019) demonstrated that real-time monitoring of plasma EBV DNA response added prognostic information, and had the potential uitility for risk-adapted treatment intensification in nasopharyngeal carcinoma. Therefore, investigators selects those with poor plasma EBV DNA response during and after induction chemotherapy, and intensifies the treatment with combination of anti-PD-1 antibody, in order to improve progression-free survival in locally advanced nasopharyngeal carcinoma, according to response-adapted strategy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T3-4N0-1M0, TANYN2-3M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: except for non-melanoma skin cancer, and the previous radiation field did not overlap with the current treatment for nasopharyngeal carcinoma
History of radiation therapy prior to standard therapy (except for non-melanoma skin cancer, and the previous radiation field did not overlap with the current treatment for nasopharyngeal carcinoma)
Cannot have received: surgical treatment
Exception: except for diagnostic biopsy
Patients who received surgical treatment (except for diagnostic biopsy)...before enrollment
Cannot have received: biological therapy
Patients who received...biological therapy...before enrollment
Cannot have received: chemotherapy
Patients who received...chemotherapy...before enrollment
Cannot have received: immunotherapy
Patients who received...immunotherapy...before enrollment
Lab requirements
Blood counts
white blood cell >4*10^9/L, neutrophil count >1.5*10^9/L, hemoglobin concentration > 90g/L, platelet count >100*10^9/L
Kidney function
creatinine clearance ≥ 60mL/min
Liver function
total bilirubin ≤1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal
Normal bone marrow function: white blood cell >4*10^9/L, neutrophil count >1.5*10^9/L, hemoglobin concentration > 90g/L, platelet count >100*10^9/L; Normal liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 60mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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