Neoadjuvant chemotherapy plus tislelizumab for advanced squamous cell cancer of the external auditory canal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Li Wang
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chunfu Dai
• Email: cfdai66@163.com
• Phone: 021-64377134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.