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Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

NCT06235203 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-06-03

No results posted yet for this study

Summary

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Conditions

  • Recurrent Nasopharyngeal Carcinoma

Interventions

PROCEDURE

endoscopic surgery

The tumor was resected by endoscopic nasopharyngectomy.

DRUG

Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy

Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.

DRUG

Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy

Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.

DRUG

Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy

Ten courses of Toripalimab Injection and four to six courses of chemotherapy,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

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
2024-07-09
Primary Completion
2027-06-30
Completion
2027-06-30

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 NCT06235203 on ClinicalTrials.gov