The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC

What this Trial Is About

Researchers are studying locally advanced head and neck squamous cell carcinoma (LAHNSCC) to evaluate the feasibility of reducing radiation treatment after induction chemotherapy combined with immunotherapy. This exploratory study involves patients who receive a combination of pembrolizumab immunotherapy and chemotherapy drugs albumin-bound paclitaxel and cisplatin before undergoing standard radiochemotherapy. The study aims to assess progression-free survival at one year and other outcomes such as overall survival, clinical response, safety, and quality of life. Participants receive two cycles of pembrolizumab at 200 mg every three weeks, alongside albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every three weeks either concurrently or sequentially. After these induction treatments, patients undergo definitive concurrent radiochemotherapy. Three months following the completion of radiotherapy, a follow-up examination is conducted to determine if salvage surgery or systemic therapy is needed based on their condition. During the study, participants will be monitored through clinical assessments including tumor evaluations per RECIST 1.1 criteria, laboratory tests for blood counts, liver, kidney, thyroid, heart, and adrenal function, and quality of life measures at six months and one year after treatment. The primary outcome measured is progression-free survival at one year, with secondary outcomes including overall survival at three years, clinical response rate at six months, safety assessments of serious adverse events, and quality of life. Participation involves regular visits and follow-up over several years to monitor these outcomes and ensure patient safety.

De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC