Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06228079

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-04

176

Participants Needed

7

Research Sites

209 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

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

CONDITIONS

Official Title

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically diagnosed with recurrent nasopharyngeal carcinoma
  • Stage rT1, rT2 (superficial parapharyngeal space, >5mm from internal carotid artery), or rT3 (confined to bottom wall of sphenoid sinus) according to AJCC 8th edition
  • Cervical lymph node metastasis can be controlled locally
  • Age 18 to 75 years
  • No distant metastasis
  • Signed informed consent forms
  • At least 6 months since completing radiation therapy before recurrence
  • Only one previous radiotherapy course
  • ECOG score 0-2 and able to tolerate chemotherapy and immunotherapy
  • Sufficient organ function
  • Undergone endoscopic surgery with negative pathological margin
Not Eligible

You will not qualify if you...

  • Participation in other interventional clinical trials
  • Uncontrolled illnesses interfering with therapy
  • Another or multiple malignancies within 5 years (except fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ)
  • Contraindications to immune therapy or chemotherapy
  • Serious autoimmune disease
  • Current use of immunosuppressive agents or systemic glucocorticoids (>10mg/day prednisone or equivalent), continuing within 2 weeks before trial drug
  • Severe allergic reactions to other monoclonal antibodies
  • History of radioactive particle implantation
  • Vaccination with live vaccine within 4 weeks before or during the study
  • Pregnancy or lactation in female patients
  • Other conditions deemed unsuitable by researchers

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

Actively 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, MD

CONTACT

Y

Yuting Lai

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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Adjuvant vs Surgery Only in Early-stage Recurrent NPC | DecenTrialz