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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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