Actively Recruiting
Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
Led by West China Hospital · Updated on 2026-04-28
6
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
CONDITIONS
Official 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
- Primary tumor located in the oral cavity, oropharynx, larynx, or hypopharynx
- Prior radical or adjuvant radiotherapy with local or regional recurrence confirmed by MRI or PET-CT
- At least 6 months between completion of last radiotherapy and recurrence
- Recurrent lesion is unresectable, patient refuses surgery, or is medically unfit for surgery
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Adequate organ and bone marrow function as defined by study parameters
- Willingness to participate and ability to comply with study procedures, including signing informed consent
You will not qualify if you...
- Presence of distant metastasis (Stage M1)
- Prior treatment with HDAC inhibitors including chidamide or vorinostat
- Major surgery or severe trauma within 4 weeks before first dose
- History of second primary malignancy except certain cured skin or bladder cancers, cervical carcinoma in situ, or gastrointestinal tract carcinoma in situ with no recurrence for 5 years
- Grade 3 or higher radiation necrosis or myelosuppression after initial radiotherapy
- Severe medical illnesses including Class II or higher cardiac insufficiency, ischemic heart disease, significant arrhythmias, reduced left ventricular ejection fraction (<50%), abnormal QTc interval, or ECG abnormalities posing additional risk
- Active Hepatitis B or C infection, or known HIV/AIDS
- Severe neurological or psychiatric illness preventing consent or compliance
- Pregnant or breastfeeding women, or those planning to conceive during study and 3 months after
- Receipt of investigational drug within 4 weeks prior to study drug or concurrent enrollment in other clinical studies except observational follow-up
- Other factors deemed by Investigator to affect ability to complete study medication and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xingchen Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here