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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEye & ENT Hospital of Fudan University

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

Qualifiers

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

Treatments tested in this trial

  • Tislelizumab

Treatment groups

50 Participants
are divided into 1 treatment group