Neoadjuvant Photoimmunotherapy in Head and Neck Cancer

头颈癌的新辅助光免疫疗法

• 批准号: 10702865
• 负责人: Vassiliki Saloura
• 金额: $ 0.97万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10702865
• 关键词: Clinical Trials; Enrollment; Excision; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and neck structure; Neoadjuvant Therapy; Newly Diagnosed; Operative Surgical Procedures; Pathologic; Patients; Phase; Progression-Free Survivals; Recurrence; Resectable; biomedical referral center; photoimmunotherapy; primary endpoint; response; secondary endpoint; skin squamous cell carcinoma; standard of care; tumor

This is a phase II neoadjuvant clinical trial investigating the efficacy of one cycle of neoadjuvant photoimmunotherapy in patients with locoregionally recurrent or newly diagnosed, surgically resectable head and neck squamous cell carcinoma or skin squamous cell carcinoma of the head and neck region. The study will be enrolling 22 patients who will be receiving one cycle of photoimmunotherapy, followed by standard of care surgery at the referral center. The primary endpoint is pathologic response (pTR-2), while secondary endpoints include overall survival, progression free survival, treatment-related AEs and percentage of patients with surgery delays due to the photoimmunotherapy treatment. NCT05182866

这是一项II期新辅助临床试验，研究了一个新辅助光免疫疗法对局部经常性或新诊断，外科手术可切除的头部和颈部鳞状细胞癌或头部和颈部皮肤鳞状细胞癌的疗效。该研究将招募22名患者，他们将接受一个摄影疗法，然后在转诊中心进行护理手术。主要终点是病理反应（PTR-2），而次要终点包括整体生存，无进展生存率，与治疗相关的AES以及由于摄影疗法治疗而导致的手术延迟患者的百分比。 NCT05182866