At a glance
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A Prospective, Single-arm Clinical Study on Re-irradiation Combined With Chidamide in the Treatment of Patients With Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
In Brief
A Phase 1 clinical trial evaluating Chidamide and radiotherapy for Head and Neck Squamous Cell Carcinoma HNSCC. Currently recruiting, targeting 6 participants across 1 site.
Detailed Summary
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
Study Details
Timeline
Interventions
Dose Escalation Design: Chidamide will be administered orally according to the protocol-specified schedule(20mg BIW). Administration Schedule: Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration). The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy.
Dose Escalation Design: Chidamide will be administered orally according to the protocol-specified schedule(30mg BIW). Administration Schedule: Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration). The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy.
All subjects receive fixed-dose Intensity-Modulated Radiation Therapy (IMRT): 60 Gy in 30 fractions (2 Gy per fraction), administered once daily, 5 days a week.