Neoadjuvant chemotherapy plus tislelizumab for advanced squamous cell cancer 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
This will test whether giving tislelizumab with induction chemotherapy before surgery helps people with locally advanced squamous cell carcinoma of the external auditory canal.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07370337 on ClinicalTrials.gov |
What this trial studies
This is a phase II, single-arm trial giving induction chemotherapy (nab-paclitaxel plus cisplatin) combined with the PD-1 antibody tislelizumab as neoadjuvant therapy for patients with cT3-4NxM0 squamous cell carcinoma of the external auditory canal. Participants will receive imaging (enhanced MRI/CT) and clinical reassessment after neoadjuvant treatment to determine tumor response and surgical planning. The study will track safety, objective response, and the rate at which important neurovascular structures (for example the facial nerve, internal carotid canal, sigmoid sinus, and posterior cranial nerves) can be preserved at surgery. Eligibility requires adults with pathologically confirmed squamous cell histology, ECOG 0-1, adequate organ function, and no prior treatment for the tumor.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with untreated, pathologically confirmed cT3-4NxM0 squamous cell carcinoma of the external auditory canal who are fit for chemotherapy and surgery (ECOG 0-1) and have adequate blood, liver, and kidney function.
Not a fit: Patients with non-squamous histology, distant metastatic disease, prior local or systemic treatment for the tumor, poor performance status, or significant organ dysfunction are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could shrink tumors before surgery and increase the chance of preserving facial nerve and other critical neurovascular structures, reducing morbidity and improving functional outcomes.
How similar studies have performed: Neoadjuvant chemotherapy combined with PD-1 inhibitors has shown promising results in other head and neck squamous cell carcinomas, but applying this specific regimen to external auditory canal cancer is largely novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 years old and ≤ 80 years old 2. Pathologically confirmed as squamous cell carcinoma 3. Suitable for enhanced MRI/CT imaging assessment 4. Previously untreated squamous cell carcinoma of the external auditory canal staged as cT3-4NxM0 according to the Pittsburgh clinical staging system 5. Cases that meet the inclusion criteria following joint discussion with otologists 6. Expected survival time of at least 1 year 7. ECOG performance status score of 0-1 8. Peripheral blood routine examination before treatment meets the following criteria: neutrophil count \> 2,000/mm³; platelet count \> 100,000/mm³ 9. Liver and kidney function tests before treatment meet the following criteria: bilirubin \< 1.5 mg/dl; AST or ALT \< 1.5 × upper limit of normal (ULN); serum creatinine \< 1.5 mg/dl; creatinine clearance rate \> 60 ml/min 10. Signed informed consent form prior to the initiation of the study Exclusion Criteria: 1. Ear tumors whose pathological type is not squamous cell carcinoma 2. Patients with early-stage (T1-T2) disease or distant metastasis (M1) 3. Cases not jointly discussed with an otologist 4. Non-first-time radiotherapy for the head and neck region 5. Hypersensitivity to platinum-based drugs or taxane drugs 6. A history of head and neck malignant tumors, or concurrent multiple primary tumors 7. Positive pregnancy test result in women of childbearing age 8. Concurrent diseases or conditions that affect the patient's normal enrollment or safety during the study period 9. Active mental disorders or other psychological conditions that impair the patient's ability to sign the informed consent form and comprehend study-related information 10. Uncontrolled active infection
Where this trial is running
Shanghai, Shanghai Municipality
- Li Wang — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Chunfu Dai
- Email: cfdai66@163.com
- Phone: 021-64377134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.