Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07370337

Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal

Led by Eye & ENT Hospital of Fudan University · Updated on 2026-01-27

50

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of induction chemotherapy combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal; to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, and posterior cranial nerves, etc.).

CONDITIONS

Official Title

Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years and less than or equal to 80 years
  • Pathological confirmation of squamous cell carcinoma
  • Suitable for enhanced MRI or CT imaging assessment
  • Previously untreated squamous cell carcinoma of the external auditory canal staged cT3-4NxM0 by Pittsburgh clinical staging
  • Cases reviewed and approved by otologists
  • Expected survival time of at least 1 year
  • ECOG performance status score of 0 or 1
  • Neutrophil count greater than 2,000/mm³ and platelet count greater than 100,000/mm³ before treatment
  • Liver and kidney function tests within specified limits before treatment
  • Signed informed consent form before study initiation
Not Eligible

You will not qualify if you...

  • Tumors not of squamous cell carcinoma type
  • Early-stage disease (T1-T2) or distant metastasis (M1)
  • Cases not reviewed with an otologist
  • Previous radiotherapy for head and neck region
  • Allergy to platinum-based or taxane drugs
  • History of head and neck cancers or multiple primary tumors
  • Positive pregnancy test in women of childbearing age
  • Any other diseases or conditions affecting safe participation
  • Active mental or psychological disorders impairing consent or understanding
  • Uncontrolled active infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Li Wang

Shanghai, Shanghai Municipality, China, 200031

Actively Recruiting

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Research Team

C

Chunfu Dai

CONTACT

X

Xinmao Song

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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