Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of External Auditory Canal, Locally Advanced Tumor. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.).
Interventions
- Drug Tislelizumab
Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).
Primary outcome measures
- Objective Response Rate （ORR） [Time frame: Two weeks after Induction Therapy]
- Preservation Rate of Neurovascular Function [Time frame: Immediately after surgery]
Secondary outcome measures (2)
- Disease-free survival ( DFS) [Time frame: 2 year]
- Overall survival （OS） [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Li Wang — Shanghai
Identifiers
NCT: NCT07370337 · 2025029