Neoadjuvant Treatment Combining JAK1 Inhibitor Sulfamethoxazole, Adebrelimab, and Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating a new combination therapy for patients with locally advanced head and neck squamous cell carcinoma HNSCC. This Phase 2 clinical trial aims to determine if adding the JAK1 inhibitor Sulfamethoxazole to the immunotherapy drug Adebrelimab and chemotherapy Nab-paclitaxel plus Cisplatin before surgery can improve the rate of complete tumor removal or shrink tumors enough to make surgery possible or less extensive. The study also tracks survival and safety outcomes to address the poor prognosis and unmet treatment needs in this condition. Participants receive neoadjuvant treatment in 21-day cycles, with cisplatin, nab-paclitaxel, and adebrelimab given on day 1, and Sulfamethoxazole started orally from day 8 to day 21 of each cycle. After two cycles, patients are assessed for surgery if eligible, with special attention to pathological response in those undergoing surgery. The trial includes patients with resectable, potentially resectable, or unresectable tumors, all receiving the same treatment regimen. Throughout the study, participants undergo regular follow-ups including imaging scans such as CT or MRI to monitor tumor response and safety. Blood and tissue samples are collected for biomarker research to identify patients most likely to benefit. The main outcomes measured are the pathological complete response rate in resectable cases and tumor shrinkage in others, with longer-term monitoring of event-free and overall survival up to three years. Safety is closely monitored up to 90 days after treatment ends.

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