Could a drug combo save nerves in ear cancer surgery?
NCT ID NCT07370337
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether giving the immunotherapy drug tislelizumab along with chemotherapy before surgery can shrink advanced squamous cell carcinoma of the ear canal. The goal is to make surgery easier and safer, especially to protect important nerves near the ear. About 50 adults with previously untreated, locally advanced tumors will receive 2-3 cycles of the drug combo, then researchers will measure how many tumors shrink and how often nerves are spared.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab combined with chemotherapy (nab-paclitaxel and cisplatin)
- What this could lead to
- If successful, this approach could shrink tumors enough to allow safer surgery, potentially preserving facial nerves and improving quality of life for patients with advanced ear canal cancer.
- What could go wrong
- This is a small, early-phase trial with only 50 participants and no comparison group. The treatment may not work better than standard care, and side effects from chemotherapy and immunotherapy can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Li Wang
RECRUITINGShanghai, Shanghai Municipality, 200031, China