Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
Eligibility criteria
Qualifiers
Age and Life Expectancy: Aged ≥18 and ≤75 years, with a life expectancy of ≥3 months, regardless of gender.
Primary tumor site located in the oral cavity, oropharynx, larynx, or hypopharynx.
History of prior radical or adjuvant radiotherapy with local/regional recurrence (confirmed by MRI/PET-CT).
The interval between the completion of the last radiotherapy and recurrence is ≥6 months (to ensure partial recovery of normal tissues).
Disqualifiers
Metastatic Disease: Presence of distant metastasis (Stage M1).
Prior treatment with HDAC inhibitors (e.g., chidamide, vorinostat), etc.
Major surgery or severe trauma within 4 weeks prior to the first dose.
Second Primary Malignancy: History of a second primary malignancy (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or carcinoma of the gastrointestinal tract in situ that has been cured with no recurrence for 5 years, or other malignancies deemed eligible by the Investigator).
Trial design
Treatments tested in this trial
- Chidamide
- Chidamide
- radiotherapy
Treatment groups
6 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov