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Adjuvant vs Surgery Only in Early-stage Recurrent NPC

NCT06228079 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2025-07-04

No results posted yet for this study

Summary

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Conditions

  • Recurrent Nasopharyngeal Carcinoma

Interventions

DRUG

Immunotherapy,Toripalimab Injection

Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

DRUG

Chemotherapy,Gemcitabine based regimen

Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • People's Hospital of Guangxi Zhuang Autonomous Region

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Hongmeng Yu · Eye& ENT Hospital, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2028-06-30
Completion
2028-06-30

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 NCT06228079 on ClinicalTrials.gov