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.
For high-risk locally advanced nasopharyngeal carcinoma, it remains essential to explore more effective treatment strategies and regimens. In the era of immunotherapy, the introduction of PD-1 monoclonal antibodies has provided significant survival benefits to patients with locally advanced nasopharyngeal carcinoma. However, different modes of intervention still warrant further exploration, and additional clinical evidence is needed for validation. In this study, the investigators designed a randomized, open-label, phase II clinical trial focusing on high-risk locally advanced nasopharyngeal carcinoma (defined as T4 or N3 or EBV DNA ≥1500 copies/ml according to AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares the sequential approach of TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus maintenance therapy with capecitabine. The study aims to provide high-quality clinical evidence to optimize treatment strategies for high-risk locally advanced nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Induction 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)
Penpulimab 200 mg every 3 weeks for 8 cycles
Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-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.
Time frame: 3 years
Overall survival
Overall survival is calculated from the date of randomization to death from any cause.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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).
Time frame: 3 years
Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group
Late adverse events (those occurring \>1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group.
Time frame: 3 years
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