Phase II Study of Sacituzumab Govitecan and Tagitanlimab as Pre-Surgery Treatment for Resectable Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Sacituzumab govitecan and Tagitanlimab as a neoadjuvant treatment for patients with resectable head and neck squamous cell carcinoma HNSCC. This Phase II, single-arm, open-label study aims to assess how well this combined therapy works in shrinking tumors before surgery, its safety, and potential biomarkers related to its effectiveness. The study also looks at participants response rates, survival time, and quality of life. Participants will receive two cycles of intravenous Sacituzumab govitecan 5 mgkg and Tagitanlimab 900 mg every two weeks. Surgical removal of the tumor and nearby lymph nodes will occur 3 to 6 weeks after completing the neoadjuvant treatment. Following surgery, patients will start adjuvant therapy 4 to 6 weeks later. Those with high-risk pathological findings will receive concurrent chemoradiotherapy plus 15 cycles of Tagitanlimab as adjuvant immunotherapy, while others with general risk factors will receive radiotherapy combined with the same Tagitanlimab regimen. During the study, participants will regularly visit the clinic for physical exams, laboratory tests, and imaging scans like MRI or CT of the head and neck. They will also provide biological samples such as blood, tumor tissue, saliva, and feces at set times for biomarker analysis. Quality-of-life questionnaires will be completed to monitor daily functioning. The main outcome measured is the major pathological response rate at surgery, with additional assessments of response rate, survival, treatment side effects, and quality of life over months to years of follow-up.

Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma