Squamous Cell Carcinoma of External Auditory CanalPhase 2NCT07370337
Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal
A Phase 2 study testing Tislelizumab in people with Squamous Cell Carcinoma of External Auditory Canal and Locally Advanced Tumor, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma of External Auditory Canal, Locally Advanced Tumor
- What is being tested?
- Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Cases that meet the inclusion criteria following joint discussion with otologists
- Expected survival time of at least 1 year
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- ECOG performance status score of 0-1
- Peripheral blood routine examination before treatment meets the following criteria: neutrophil count > 2,000/mm³; platelet count > 100,000/mm³
- 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
- Signed informed consent form prior to the initiation of the study
Who cannot join
- 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
- Hypersensitivity to platinum-based drugs or taxane drugs
- A history of head and neck malignant tumors, or concurrent multiple primary tumors
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- Positive pregnancy test result in women of childbearing age
- Concurrent diseases or conditions that affect the patient's normal enrollment or safety during the study period
- Active mental disorders or other psychological conditions that impair the patient's ability to sign the informed consent form and comprehend study-related information
- Uncontrolled active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Li Wang
Shanghai, Shanghai Municipality, 200031
Li Wang, 021-34233877, wangli20170515@163.com
Chunfu Dai
About this study
Official title: 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
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.).
Read the detailed description
The main reasons for the poor prognosis of advanced squamous cell carcinoma of the external auditory canal are the strong local invasiveness of the tumor, the complexity of the adjacent anatomical structures, the high difficulty in complete tumor resection, and the imperfection of comprehensive treatment strategies. In this phase II single-arm clinical study, the investigators aimed to evaluate the efficacy and safety of induction chemotherapy (nab-paclitaxel plus cisplatin) combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal, and to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, posterior cranial nerves, etc.).
- Being tested
- Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called Neoadjuvant chemotherapy
Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
| Study group | Role | What they receive |
|---|---|---|
| Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC | Experimental | Not described Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate （ORR）
Objective Response Rate after Induction Therapy
Measured: Two weeks after Induction Therapy
Preservation Rate of Neurovascular Function
Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)
Measured: Immediately after surgery
Secondary outcomes (2)
Disease-free survival ( DFS)
Measured: 2 year
Overall survival （OS）
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start12 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of External Auditory CanalStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinmao Song, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370337
- Sponsor's protocol ID
- 2025029
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07370337
- Acronym / sponsor ID
- 2025029
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Detailed description
The main reasons for the poor prognosis of advanced squamous cell carcinoma of the external auditory canal are the strong local invasiveness of the tumor, the complexity of the adjacent anatomical structures, the high difficulty in complete tumor resection, and the imperfection of comprehensive treatment strategies. In this phase II single-arm clinical study, the investigators aimed to evaluate the efficacy and safety of induction chemotherapy (nab-paclitaxel plus cisplatin) combined with tislelizumab as neoadjuvant therapy in patients with locally advanced squamous cell carcinoma of the external auditory canal, and to explore the improvement in the preservation rate of important neurovascular structures (including the facial nerve, internal carotid artery canal, sigmoid sinus, posterior cranial nerves, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC | Experimental | Drug: Tislelizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Cases that meet the inclusion criteria following joint discussion with otologists
Key exclusion criteria (10 listed)
- 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
- Hypersensitivity to platinum-based drugs or taxane drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: Neoadjuvant chemotherapyEligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin). | Drug | Induction Chemotherapy Combined with Tislelizumab for Locally Advanced SCC of the EAC |
Primary outcome
Objective Response Rate （ORR）
Time frame: Two weeks after Induction Therapy
Objective Response Rate after Induction Therapy
Preservation Rate of Neurovascular Function
Time frame: Immediately after surgery
Preservation Rate of Neurovascular Function (Facial Nerve, Carotid Artery Canal, Sigmoid Sinus, Posterior Cranial Nerves)
2 secondary outcomes
Disease-free survival ( DFS)
Time frame: 2 year
Overall survival （OS）
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Squamous Cell Carcinoma of External Auditory Canal and Locally Advanced Tumor, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunfu Dai (021-64377134, cfdai66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate （ORR） (time frame: Two weeks after Induction Therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.