Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy

Recruiting now · Phase 1

Conditions studied: Head and Neck Squamous Cell Carcinoma HNSCC

In brief

To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.

Key facts

Study ID

NCT07545967

Run by

West China Hospital

People needed

6

Starts

2026-04-23

Expected to finish

2027-07-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age and Life Expectancy: Aged ≥18 and ≤75 years, with a life expectancy of ≥3 months, regardless of gender.
• Diagnosis and History: Patients with histologically confirmed head and neck squamous cell carcinoma meeting the following conditions:
• 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).
• Surgical Status: The recurrent lesion is deemed unresectable by a head and neck surgeon, or the patient refuses surgery, or is medically unfit to tolerate surgery.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Organ and Marrow Function: Adequate organ and bone marrow function, defined as follows:
• Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥80×10⁹/L; Hemoglobin ≥8 g/dL.
• Liver Function: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤2.5× Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤1.5×ULN.
• Albumin: Serum Albumin ≥2.8 g/dL.
• Renal Function: Serum Creatinine (Cr) ≤1.5×ULN OR Creatinine Clearance (CrCl) >60 mL/min.
• Coagulation: International Normalized Ratio (INR) ≤1.5; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.
• Consent: Willingness to participate in the study, evidenced by signing the Informed Consent Form (ICF), and ability to comply with scheduled visits and related procedures.

You may not qualify if…

• Metastatic Disease: Presence of distant metastasis (Stage M1).
• Prior Therapy: Receipt of any of the following treatments:
• 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).
• Prior Toxicity: Occurrence of Grade ≥3 radiation necrosis or myelosuppression following the initial radiotherapy.
• Medical Comorbidities: Presence of severe medical illnesses, such as:
• Cardiac insufficiency Class II or higher (NYHA criteria);
• Ischemic heart disease (e.g., myocardial infarction or angina pectoris);
• Clinically significant supraventricular or ventricular arrhythmias;
• Left Ventricular Ejection Fraction (LVEF) <50% as determined by echocardiogram;
• QTc interval >450 msec for males or >470 msec for females;
• Abnormal Electrocardiogram(ECG) findings that the Investigator considers to pose an additional risk for the investigational drug.
• Infectious Disease: Presence of active Hepatitis B (Hepatitis B Virus Deoxyribonucleic Acid ≥2000 IU/ml or 10⁴ copies/ml) or Hepatitis C (Hepatitis C Virus antibody positive and Hepatitis C Virus Ribonucleic Acid above the lower limit of detection of the assay), or a known history of positive Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
• Psychiatric Disorders: Any severe neurological or psychiatric illness that may prevent the patient from providing informed consent or complying with study procedures.
• Reproductive Status: Women who are pregnant or breastfeeding; subjects (and their partners) who plan to conceive during the screening period up to 3 months after the end of the study; or women of childbearing potential who are not using effective contraceptive methods.
• Investigational Drugs: Receipt of any investigational drug within 4 weeks prior to the first dose of the study drug, or concurrent enrollment in another clinical study, unless it is for observational or interventional clinical study follow-up.
• Investigator Discretion: Other factors determined by the Investigator that may affect the subject's ability to complete the study medication and follow-up.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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