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Clinical Trials in China / NCT07370337
Recruiting Phase 2

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

NCT07370337 · tracked via the Priya Life Science China tracker
Sponsor
Eye & ENT Hospital of Fudan University
Phase
Phase 2
Started
2025-05-12
Last updated
2026-01-27

Condition(s) studied

Squamous Cell Carcinoma of External Auditory CanalLocally Advanced Tumor

Investigational drug(s) / intervention(s)

Tislelizumab →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Li Wang Shanghai Shanghai Municipality Recruiting

More Eye & ENT Hospital of Fudan University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07370337 on ClinicalTrials.gov ↗ ← All trials in China