Phase 1 Study of Chidamide With Re-irradiation for Adults With Recurrent Head and Neck Squamous Cell Carcinoma After Prior Radiotherapy

What this Trial Is About

This research aims to systematically assess the safety and tolerability of combining the drug chidamide with re-irradiation treatment in adults who have recurrent head and neck squamous cell carcinoma after previous radiotherapy. The study focuses on measuring dose-limiting toxicity during the dose-escalation phase to understand potential side effects. Participants will receive a 6-week course of intensity-modulated radiation therapy IMRT combined with chidamide. The treatment involves two dose levels of chidamide 20 mg or 30 mg, taken orally twice weekly with at least three days between doses, starting one week before the radiation therapy to reach steady drug levels. The radiotherapy is fixed at 60 Gy delivered in 30 fractions over six weeks, administered once daily five days a week. During the study, participants will be closely monitored for safety through clinical evaluations, laboratory tests, and adverse event grading. Researchers will track treatment responses and survival outcomes up to one year after therapy. The primary outcome is the incidence of dose-limiting toxicity from the first chidamide dose until 30 days after finishing radiotherapy. Follow-up includes ongoing safety and disease status monitoring to evaluate treatment effects and participant health over time.

Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy