Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

September 25, 2025

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2031

Conditions
Locally Advanced Nasopharyngeal Carcinoma
Interventions
RADIATION

Radiotherapy

"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."

DRUG

Serplulimab

Serplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.

DRUG

Cisplatin

On days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg/m² via intravenous infusion.

Trial Locations (1)

430022

Wuhan Union Hospital, Wuhan

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER