NCT07370337

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.).

Detailed description

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.).

Conditions

• Squamous Cell Carcinoma of External Auditory Canal
• Locally Advanced Tumor

Interventions

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

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: China