Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal
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
Eye & ENT Hospital of Fudan University
50 participants
May 12, 2025
INTERVENTIONAL
Conditions
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.).
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria10
- 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
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Interventions
Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
Locations(1)
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NCT07370337