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

Recruiting now · Phase 2

Conditions studied: Squamous Cell Carcinoma of External Auditory Canal, Locally Advanced Tumor

In brief

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.).

Key facts

Study ID

NCT07370337

Run by

Eye & ENT Hospital of Fudan University

People needed

50

Starts

2025-05-12

Expected to finish

2029-12-31

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• Cases that meet the inclusion criteria following joint discussion with otologists
• 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

Where it is running

• Li Wang — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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