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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EACExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate after Induction Therapy

Time frame
Two weeks after Induction Therapy
2

Preservation Rate of Neurovascular Function

Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)

Time frame
Immediately after surgery

Secondary outcomes

1

Disease-free survival ( DFS)

Time frame
2 year
2

Overall survival (OS)

Time frame
2 year

Other outcomes

Sponsors and contacts

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