Hypopharyngeal Squamous Cell Carcinoma Clinical Trial
Official title:
A Single-arm Study Evaluating Efficacy and Safety of Toripalimab Combined With Docetaxel and Cisplatin as Induced Chemotherapy in the Treatment of Localized Hypopharyngeal Squamous Cell Carcinoma
60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the curative effect, and established an organ function preservation treatment strategy. Induction chemotherapy can reduce tumor burden and reduce distant metastases. At present, induction chemotherapy followed by concurrent chemoradiotherapy has become the standard treatment for the laryngeal preservation in locally advanced hypopharyngeal and laryngeal cancer. This study aimed to investigate the efficacy and safety of a PD-1 inhibitor toripalimab combined with chemotherapy as induction therapy in hypopharyngeal cancer.
This is a phase II, multicenter, open-label, single-arm study, planned to enroll 100 patients with localized hypopharyngeal squamous cell carcinoma who are newly treated and could accept radical treatment. Patients would be treated with toripalimab combined with docetaxel and cisplatin for two cycles. After the induction chemotherapy is completed, the investigator choose appropriate radical treatment (surgery or chemoradiotherapy) based on tumor evaluation. The primary endpoint is overall objective rate (ORR), the second endpoint include major pathologic response (MPR), 2-year DFS for surgery patients, 2-year PFS for radiotherapy patients, OS and QOL. ;
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