NCT07370337

Brief Summary

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.).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
43mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
May 2025Dec 2029

Study Start

First participant enrolled

May 12, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 13, 2026

Last Update Submit

January 17, 2026

Conditions

Locally Advanced TumorSquamous Cell Carcinoma of External Auditory Canal

Outcome Measures

Primary Outcomes (2)

  • Objective Response Rate （ORR）

    Objective Response Rate after Induction Therapy

    Two weeks after Induction Therapy

  • Preservation Rate of Neurovascular Function

    Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)

    Immediately after surgery

Secondary Outcomes (2)

  • Disease-free survival ( DFS)

    2 year

  • Overall survival （OS）

    2 year

Study Arms (1)

Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC

EXPERIMENTAL
Drug: Tislelizumab

Interventions

TislelizumabDRUG

Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).

Also known as: Neoadjuvant chemotherapy
Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old and ≤ 80 years old
  • Pathologically confirmed as squamous cell carcinoma
  • Suitable for enhanced MRI/CT imaging assessment
  • Previously untreated squamous cell carcinoma of the external auditory canal staged as cT3-4NxM0 according to the Pittsburgh clinical staging system
  • Expected survival time of at least 1 year
  • ECOG performance status score of 0-1
  • Peripheral blood routine examination before treatment meets the following criteria: neutrophil count \> 2,000/mm³; platelet count \> 100,000/mm³
  • 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
  • Signed informed consent form prior to the initiation of the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Wang

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

tislelizumabNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Chunfu Dai

CONTACT

021-64377134cfdai66@163.com

Xinmao Song

CONTACT

021-34233877muqinger@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 27, 2026

Study Start

May 12, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

CN(1)