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A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
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.
Official title: A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2026-02-04
Completion Date
2033-02-04
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
TP+PD1+CCRT
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)
PD-1 Monoclonal Antibody
Penpulimab 200 mg every 3 weeks for 8 cycles
Capecitabine
Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China