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

RecruitingPhase 2Ages 18 Years - 80 YearsAllEye & ENT Hospital of Fudan University
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In plain words

What the trial is, and whether it could suit you

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.).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Tislelizumab
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Where

1 site
Li Wang
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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