Phase 1 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old, with a life expectancy of at least 3 months.
• People who have been diagnosed with a specific type of head and neck cancer (squamous cell carcinoma), confirmed by a tissue sample (biopsy), where the cancer started in the mouth, throat, voice box, or the area just below the throat.
• People whose cancer has come back in the same area (local or regional recurrence) after previously receiving radiotherapy as a main or additional treatment, confirmed by MRI or PET-CT scan.
• People whose cancer returned at least 6 months after finishing their last course of radiotherapy.
• People whose returned cancer cannot be removed by surgery, either because a specialist surgeon has determined it is not surgically removable, because the person has declined surgery, or because their overall health makes surgery too risky.
• People who are generally well enough to carry out daily activities with little to no limitation (this is measured using a standard medical scale called ECOG, with a score of 0 or 1).
• People whose blood counts, liver function, kidney function, protein levels, and blood clotting results meet the minimum thresholds required by the trial (confirm specific values with the trial site).
• People who are willing and able to give written consent to participate and to attend scheduled visits and follow the study procedures.

Who may not be able to join:

• People whose cancer has spread to distant parts of the body (stage M1 metastatic disease).
• People who have previously been treated with a class of drugs called HDAC inhibitors (such as chidamide or vorinostat).
• People who have had major surgery or a serious physical injury within 4 weeks before the trial start date.
• People with a history of a second, separate cancer — although some exceptions may apply, such as certain skin cancers, early-stage bladder or cervical cancer, certain gastrointestinal cancers that have been fully treated with no recurrence for at least 5 years, or other cancers the trial investigator considers acceptable (confirm with trial site).
• People who experienced severe radiation damage to healthy tissue or severe bone marrow suppression (grade 3 or higher) following their original radiotherapy.
• People with significant heart problems, including moderate-to-severe heart failure, a history of heart attack or angina, certain abnormal heart rhythms, reduced heart pumping function, or abnormal results on a heart tracing (ECG) test (confirm specific thresholds with trial site).
• People with active hepatitis B or hepatitis C infection at levels above certain thresholds, or a known history of HIV or AIDS.
• People with a severe neurological or psychiatric condition that may prevent them from giving informed consent or following the study procedures.
• People who are pregnant or breastfeeding; people (or their partners) who plan to become pregnant during the study period or within 3 months after it ends; and women who are capable of becoming pregnant but are not using effective contraception.
• People who have taken part in another clinical trial or received an experimental drug within 4 weeks before the trial start date (observational study follow-up may be an exception — confirm with trial site).
• People who, in the investigator's judgement, have other circumstances that may prevent them from completing the study treatment and follow-up.

Important: Always verify eligibility with the trial site directly before applying.