In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Voluntary participation and written informed consent must be signed.
Age between 18 and 70 years, male or non-pregnant female.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
Patients who have previously received radiotherapy or systemic chemotherapy.
Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
Parallel
TP+PD1+CCRT
DrugInduction Chemoimmunotherapy (3 cycles, Q3W): Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks. Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W): concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT)
PD-1 Monoclonal Antibody
DrugPenpulimab 200 mg every 3 weeks for 8 cycles
Capecitabine
DrugCapecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.
Progression-free survival
Progression-free survival is calculated from the date of randomization to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Overall survival
Overall survival is calculated from the date of randomization to death from any cause.
Locoregional recurrence-free survival
Locoregional recurrence-free survival is calculated from the date of randomization to the date of documented locoregional recurrence or death from any cause.
Distant metastasis-free survival
Distant metastasis-free survival is calculated from the date of randomization to the date of documented distant metastasis or death from any cause.
Incidence of acute toxicity as assessed by CTCAE v5.0
Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0).
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