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PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT05340270 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-11

No results posted yet for this study

Summary

The purpose of this Phase II, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.

Conditions

  • Nasopharyngeal Carcinoma
  • Neoadjuvant Therapy
  • PD-1 Inhibitor

Interventions

DRUG

PD-1 inhibitor+GP

PD-1 inhibitor (200-240mg), gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.

DRUG

GP

Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.

Sponsors & Collaborators

  • Hainan People's Hospital

    collaborator OTHER

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • First People's Hospital of Yulin

    collaborator OTHER

  • Fourth Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Guigang People's Hospital

    collaborator OTHER

  • LiuZhou People's Hospital

    collaborator OTHER

  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER

  • Guangxi Medical University

    lead OTHER

Principal Investigators

  • RENSHENG WANG, MD · First Affiliated Hospital of Guangxi Medical University

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
2022-07-15
Primary Completion
2026-03-29
Completion
2029-03-29

Countries

  • China

Study Locations

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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 NCT05340270 on ClinicalTrials.gov