Actively Recruiting
A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-09
76
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG Performance Status of 0-1
- Histologically or cytologically confirmed Stage III-IVA head and neck squamous cell carcinoma
- Classified as resectable, potentially resectable, or unresectable locally advanced disease per Asia-Pacific consensus
- Peripheral blood showing PD-1+TIM-3+CD8+ exhausted T cells >10% of CD8+ T cells
- Adequate organ function within 14 days before enrollment including blood counts, kidney, and liver function
- Ability and willingness to sign informed consent and comply with study procedures and follow-up
You will not qualify if you...
- Prior immunotherapy or JAK inhibitor treatment or severe allergic reactions to monoclonal antibodies
- Active autoimmune diseases or need for immunosuppressive therapy before enrollment
- History of other active cancers or uncontrolled infections including HIV, hepatitis, or tuberculosis
- Severe heart or lung problems, coagulation disorders, bleeding tendencies, or current blood-thinning treatments
- Pregnant or breastfeeding women or unwillingness to use effective contraception during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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