NCT07370337 Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal
| NCT ID | NCT07370337 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Squamous Cell Carcinoma of External Auditory Canal |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-05-12 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07370337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Squamous Cell Carcinoma of External Auditory Canal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07370337 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07370337 currently recruiting?
Yes, NCT07370337 is actively recruiting participants. Contact the research team at cfdai66@163.com for enrollment information.
Where is the NCT07370337 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07370337 clinical trial?
NCT07370337 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 50 participants.