RecruitingPhase 2NCT07457346

A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer

A Pilot Trial of Neoadjuvant Sulfate Emactinib Plus Chemo-immunotherapy for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

76 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of a novel combination therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). The therapy combines the JAK1 inhibitor Sulfamethoxazole, the anti-PD-L1 antibody Adebrelimab, and chemotherapy (Nab-paclitaxel + Cisplatin) as a neoadjuvant treatment (given before surgery). The main questions it aims to answer are: * For patients with resectable locally advanced HNSCC: Can this combination improve the pathological complete response (pCR) rate (the absence of viable cancer cells in the surgical specimen) compared to current neoadjuvant therapies? * For patients with potentially resectable or unresectable locally advanced HNSCC: Can this combination improve the objective response rate (ORR) (the percentage of patients with significant tumor shrinkage), potentially making surgery possible or reducing its scope? Researchers will also assess secondary outcomes including event-free survival (EFS), overall survival (OS), and the safety profile of the combination. Participants will: * Receive neoadjuvant treatment with the combination of Sulfamethoxazole, Adebrelimab, and chemotherapy. A key feature is the timed sequencing of the JAK inhibitor, which will be started on day 8 of each treatment cycle. * Be evaluated for surgery after the neoadjuvant treatment. For those who undergo surgery, the pathological response will be analyzed. * Have regular follow-up assessments, including imaging studies (such as CT or MRI scans) and safety monitoring, to evaluate long-term treatment response, survival, and side effects. * Provide tissue and/or blood samples for exploratory biomarker analysis (e.g., Interferon-Stimulated Gene signature) to help identify patients who benefit most from this treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of emactinib sulfate (a targeted drug that blocks certain immune-suppressing signals in the tumor), immunotherapy, and chemotherapy given before surgery for patients with stage III–IVA head and neck squamous cell cancer (throat, mouth, or voice box cancer). The goal is to shrink the tumor before surgery and help patients tolerate the operation better. **You may be eligible if...** - You are 18 or older with confirmed stage III–IVA head and neck squamous cell cancer - Your cancer is classified as resectable, potentially resectable, or unresectable based on surgeon assessment - A blood test shows that a specific type of exhausted immune cell makes up more than 10% of your immune cells - Your organ function meets required minimum levels - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have previously received immunotherapy (anti-PD-1/PD-L1/CTLA-4) or JAK inhibitors - You have an active autoimmune disease requiring immunosuppressive therapy - You have active tuberculosis, HIV, active hepatitis B or C, or another active infection - You have severe heart or lung dysfunction - You are pregnant or breastfeeding 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.

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Interventions

DRUGcisplatin+ nab-paclitaxel +adebrelimab + imaxitinib

Treatment is administered in 21-day cycles, with a response assessment after 2 cycles. On Day 1 of each cycle, patients receive cisplatin (60mg/m²) plus nab-paclitaxel (260mg/m²) concurrently with adebrelimab (1200mg). Starting from Day 8 through Day 21 of each cycle, patients orally take 4mg of imaxitinib daily.


Locations(1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China

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NCT07457346


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