Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06235203

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Led by Eye & ENT Hospital of Fudan University · Updated on 2025-06-03

154

Participants Needed

7

Research Sites

155 weeks

Total Duration

On this page

Sponsors

E

Eye & ENT Hospital of Fudan University

Lead Sponsor

S

Shanghai Zhongshan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with recurrent nasopharyngeal carcinoma confirmed by pathology
  • Disease staging rT2, rT3, or rT4 according to AJCC 8th edition
  • Cervical lymph node metastasis controllable locally
  • Aged between 18 and 75 years
  • Signed informed consent to participate in the trial
  • No distant metastasis
  • At least 6 months since completing radical radiation therapy before recurrence
  • Only one previous course of radiotherapy received
  • Sufficient organ function
  • ECOG performance status score between 0 and 2, able to tolerate surgery, chemotherapy, and immunotherapy
Not Eligible

You will not qualify if you...

  • Currently participating in other interventional clinical trials
  • Having uncontrolled illnesses that could interfere with the therapy
  • Diagnosed with another or multiple cancers within the last 5 years (except fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.)
  • Any contraindication to surgery
  • Having serious autoimmune disease
  • Using immunosuppressive agents or systemic hormone therapy (more than 10 mg/day prednisone or equivalent) within 2 weeks prior to first treatment
  • Experiencing severe allergic reactions to monoclonal antibodies
  • History of radioactive particle implantation
  • Received live vaccine within 4 weeks before starting the study or during the study
  • Female who is pregnant or breastfeeding
  • Other conditions judged by researchers to make participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200031

Actively Recruiting

2

Fujian Medical University Union Hospital

Fuzhou, China

Not Yet Recruiting

3

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Actively Recruiting

4

Changhai Hospital

Shanghai, China

Not Yet Recruiting

5

Shanghai Sixth People's Hospital

Shanghai, China

Not Yet Recruiting

6

Shanghai Zhongshan Hospital

Shanghai, China

Not Yet Recruiting

7

Shenzhen Second People's Hospital

Shenzhen, China

Not Yet Recruiting

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Research Team

X

Xiaole Song

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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