Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cel… (NCT07545967) | Clinical Trial Compass
RecruitingPhase 1
Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
China6 participantsStarted 2026-04-23
Plain-language summary
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: From the first dose of chidamide to 30 days after the completion of radiotherapy.
✕. 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);