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

NCT07457346 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Head and Neck Cancer Squamous Cell Carcinoma

Interventions

DRUG

cisplatin+ 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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-08-30
Completion
2030-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457346 on ClinicalTrials.gov