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Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

NCT07177443 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-09-17

No results posted yet for this study

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).

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177443 on ClinicalTrials.gov