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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.).
The main reasons for the poor prognosis of advanced squamous cell carcinoma of the external auditory canal are the strong local invasiveness of the tumor, the complexity of the adjacent anatomical structures, the high difficulty in complete tumor resection, and the imperfection of comprehensive treatment strategies. In this phase II single-arm clinical study, the investigators aimed to evaluate the efficacy and safety of induction chemotherapy (nab-paclitaxel plus cisplatin) combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal, and to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, posterior cranial nerves, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate after Induction Therapy | Two weeks after Induction Therapy |
| Preservation Rate of Neurovascular Function | Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves) | Immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival ( DFS) | 2 year | |
| Overall survival (OS) | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunfu Dai | Contact | 021-64377134 | cfdai66@163.com | |
| Xinmao Song | Contact | 021-34233877 | muqinger@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Li Wang | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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|
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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