Actively Recruiting
Re-irradiation Combined With Chidamide for Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy A Prospective, Single-arm Clinical Study
Led by West China Hospital · Updated on 2026-04-28
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years with a life expectancy of at least 3 months
- Histologically confirmed head and neck squamous cell carcinoma with primary tumor in oral cavity, oropharynx, larynx, or hypopharynx
- History of prior radical or adjuvant radiotherapy with local/regional recurrence confirmed by MRI or PET-CT
- At least 6 months since last radiotherapy to recurrence
- Recurrent lesion unresectable, patient refuses surgery, or medically unfit for surgery
- ECOG performance status 0 to 1
- Adequate organ and marrow function as defined by blood counts, liver and kidney function, and coagulation parameters
- Willingness to participate and ability to comply with study procedures by signing informed consent
You will not qualify if you...
- Presence of distant metastasis (Stage M1)
- Prior treatment with HDAC inhibitors or major surgery/severe trauma within 4 weeks before first dose
- History of second primary malignancy except certain skin and bladder cancers or cured in situ gastrointestinal or cervical cancers
- Grade 3 or higher radiation necrosis or myelosuppression after initial radiotherapy
- Severe medical illnesses including cardiac insufficiency Class II or higher, ischemic heart disease, significant arrhythmias, LVEF less than 50%, QTc interval above specified limits, or abnormal ECG posing additional risk
- Active hepatitis B or C infection, or known HIV/AIDS
- Severe neurological or psychiatric illness preventing informed consent or compliance
- Pregnancy, breastfeeding, or plans to conceive during study and follow-up period
- Recent investigational drug use within 4 weeks or concurrent enrollment in other clinical studies except for follow-up
- Other investigator-determined factors affecting ability to complete study medication and follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants begin oral chidamide treatment 1 week prior to starting re-irradiation to achieve steady-state plasma concentration.
1 visit to initiate chidamide treatment
Duration - 6 weeks
Participants receive a 6-week course of intensity-modulated radiation therapy combined with chidamide taken orally twice weekly during radiotherapy.
Daily visits for radiation therapy (5 days per week) and twice weekly chidamide dosing
Duration - Up to 1 year
Participants undergo safety monitoring and long-term monitoring for disease status and survival outcomes after treatment completion.
Visits scheduled according to protocol for safety and disease monitoring
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xingchen Peng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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