RecruitingPhase 2NCT07370337

Induction Chemotherapy Combined With Tislelizumab for Locally Advanced Squamous Cell Carcinoma of the External Auditory Canal

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


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

50 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (tislelizumab) to standard chemotherapy before surgery can improve outcomes for people with advanced squamous cell carcinoma (cancer) of the ear canal. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with squamous cell carcinoma of the external auditory canal (ear canal) at an advanced stage (cT3–T4) - You have not received any prior treatment for this cancer - You are in good physical condition (ECOG 0–1) - Your blood counts and organ function (liver, kidneys) are within acceptable ranges **You may NOT be eligible if...** - Your ear cancer is not squamous cell carcinoma, or is early stage or has spread to distant organs - You have previously had radiation to the head and neck - You are allergic to platinum-based or taxane chemotherapy drugs - You have a history of head and neck cancer or multiple primary cancers - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTislelizumab

Eligible patients will receive 2-3 cycles of neoadjuvant therapy consisting of tislelizumab combined with the AP chemotherapy regimen (nab-paclitaxel+ cisplatin).


Locations(1)

Li Wang

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07370337