Phase 2 Study of Toripalimab with Cisplatin and Docetaxel Induction Therapy for CPS-Positive Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and tolerability of toripalimab combined with cisplatin and docetaxel as an induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma HNSCC. This is a phase II study using a Simon two-stage design to assess treatment-related adverse events and treatment effectiveness. The investigational combination aims to enhance the immune systems attack on cancer cells, with toripalimab being a lab-made antibody currently approved for other head and neck cancers. Cisplatin and docetaxel are chemotherapy agents approved for various cancers, including head and neck cancer. Participants will receive toripalimab, cisplatin, and docetaxel by intravenous infusion every 21 days for up to three cycles or until disease progression or unacceptable side effects occur. Each cycle involves administering toripalimab over about 60 minutes, followed by docetaxel and then cisplatin. Participants may be pre-medicated to reduce sensitivity reactions. After induction therapy, patients may receive chemoradiotherapy with weekly cisplatin as determined by a specialized multidisciplinary team. Throughout the study, participants will be monitored for adverse events and efficacy for up to two years from registration. Assessments include tracking the proportion of participants free from severe treatment-related adverse events during induction and curative-intent therapy, overall response rates, survival outcomes, and quality of life measures. The study provides careful safety monitoring and follows patients closely to evaluate the investigational treatment combination.

PDT For Induction Therapy For Head And Neck Cancer