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

January 17, 2026 updated by: Xinmao Song, Eye & ENT Hospital of Fudan University

Phase II, Single-Arm, Multicenter Clinical Study of Induction Chemotherapy Combined With Tislelizumab as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal

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.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main reasons for the poor prognosis of advanced squamous cell carcinoma of the external auditory canal are the strong local invasiveness of the tumor, the complexity of the adjacent anatomical structures, the high difficulty in complete tumor resection, and the imperfection of comprehensive treatment strategies. In this phase II single-arm clinical study, the investigators aimed to evaluate the efficacy and safety of induction chemotherapy (nab-paclitaxel plus cisplatin) combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal, and to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, posterior cranial nerves, etc.).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Recruiting
        • Li Wang
        • Contact:
        • Principal Investigator:
          • Chunfu Dai
        • Sub-Investigator:
          • Xinmao Song
        • Sub-Investigator:
          • Xiaoshen Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18 years old and ≤ 80 years old
  2. Pathologically confirmed as squamous cell carcinoma
  3. Suitable for enhanced MRI/CT imaging assessment
  4. Previously untreated squamous cell carcinoma of the external auditory canal staged as cT3-4NxM0 according to the Pittsburgh clinical staging system
  5. Cases that meet the inclusion criteria following joint discussion with otologists
  6. Expected survival time of at least 1 year
  7. ECOG performance status score of 0-1
  8. Peripheral blood routine examination before treatment meets the following criteria: neutrophil count > 2,000/mm³; platelet count > 100,000/mm³
  9. Liver and kidney function tests before treatment meet the following criteria: bilirubin < 1.5 mg/dl; AST or ALT < 1.5 × upper limit of normal (ULN); serum creatinine < 1.5 mg/dl; creatinine clearance rate > 60 ml/min
  10. Signed informed consent form prior to the initiation of the study

Exclusion Criteria:

  1. Ear tumors whose pathological type is not squamous cell carcinoma
  2. Patients with early-stage (T1-T2) disease or distant metastasis (M1)
  3. Cases not jointly discussed with an otologist
  4. Non-first-time radiotherapy for the head and neck region
  5. Hypersensitivity to platinum-based drugs or taxane drugs
  6. A history of head and neck malignant tumors, or concurrent multiple primary tumors
  7. Positive pregnancy test result in women of childbearing age
  8. Concurrent diseases or conditions that affect the patient's normal enrollment or safety during the study period
  9. Active mental disorders or other psychological conditions that impair the patient's ability to sign the informed consent form and comprehend study-related information
  10. Uncontrolled active infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC
Drug: Tislelizumab
Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
Other Names:
  • Neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate （ORR）
Time Frame: Two weeks after Induction Therapy
Objective Response Rate after Induction Therapy
Two weeks after Induction Therapy
Preservation Rate of Neurovascular Function
Time Frame: Immediately after surgery
Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)
Immediately after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival ( DFS)
Time Frame: 2 year
2 year
Overall survival （OS）
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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