OncoMatch/Clinical Trials/NCT05628922
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
Is NCT05628922 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT05628922 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T3-4N0-1M0 or TANYN2-3M0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages