Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma
Induction Chemotherapy Combined With Serplulimab Induction/Maintenance Therapy and Omission of Concurrent Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma (UNION-NPC-001): A Multicenter, Open-Label, Randomized, Controlled, Phase III, Non-Inferiority Clinical Trial
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
710 participants
Sep 26, 2025
INTERVENTIONAL
Conditions
Summary
This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction/maintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Following induction therapy, eligible patients will receive radiotherapy alone or concurrent chemoradiotherapy per protocol. Photon or proton radiotherapy techniques were permitted. Prescribed doses were: Primary tumor and metastatic lymph nodes: 70 Gy/33 fractions High-risk lymphatic drainage areas: 60 Gy/33 fractions Low-risk regions: 54 Gy/33 fractions PTV dose specifications: GTVnx: 70 Gy GTVnd: 66-70 Gy (reducible to 63 Gy for suspicious small nodes) CTV1: 60-62 Gy CTV2: 54-56 Gy All treatments will employ simultaneous integrated boost (SIB) intensity-modulated radiotherapy delivered once daily, 5 fractions per week.
Serplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.
On days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg/m² via intravenous infusion.
Locations(1)
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NCT07177443