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Clinical Trial NCT07370337 for Squamous Cell Carcinoma of External Auditory Canal, Locally Advanced Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal Phase 2 50

Recruiting
Clinical Trial NCT07370337 is designed to study Treatment for Squamous Cell Carcinoma of External Auditory Canal, Locally Advanced Tumor. It is a Phase 2 interventional study that is recruiting, having started on May 12, 2025, with plans to enroll 50 participants. Led by Eye & ENT Hospital of Fudan University, it is expected to complete by December 31, 2029. The latest data from ClinicalTrials.gov was last updated on January 27, 2026.
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.).
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 safet...Show More
Official Title

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

Conditions
Squamous Cell Carcinoma of External Auditory CanalLocally Advanced Tumor
Other Study IDs
  • 2025029
NCT ID Number
NCT07370337
Start Date (Actual)
2025-05-12
Last Update Posted
2026-01-27
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalInduction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC
Tislelizumab
Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Disease-free survival ( DFS)
2 year
Overall survival （OS）
2 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
Eye & ENT Hospital of Fudan University logoEye & ENT Hospital of Fudan University
Study Responsible Party
Xinmao Song, Principal Investigator, Associate chief physician, Eye & ENT Hospital of Fudan University
Study Central Contact
Contact: Chunfu Dai, 021-64377134, [email protected]
Contact: Xinmao Song, 021-34233877, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Li Wang, Shanghai, Shanghai Municipality, 200031, China
Li Wang, Contact, 021-34233877, [email protected]
Chunfu Dai, Principal Investigator
Xinmao Song, Sub-Investigator
Xiaoshen Wang, Sub-Investigator
Recruiting