About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Tislelizumab
DrugEligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
Objective Response Rate after Induction Therapy
Preservation Rate of Neurovascular Function
Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)
Secondary outcomes
Disease-free survival ( DFS)
Overall survival (OS)
Sponsors and contacts
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