Experimental combo aims to tackle returning head and neck cancer
NCT ID NCT07545967
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing whether giving a drug called chidamide along with a second round of radiation is safe for people whose head and neck cancer has returned after previous radiation. Only 6 participants will be enrolled to find the best dose and check for side effects. The goal is to see if this combination can help control the cancer without causing too many severe problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chidamide (a type of drug called a histone deacetylase inhibitor, taken orally)
- What this could lead to
- If successful, this could point toward a new treatment option for patients whose head and neck cancer has come back after radiation therapy.
- What could go wrong
- This is a very early, small Phase 1 trial with only 6 participants, so results may not apply broadly. The combination of re-irradiation and chidamide may cause serious side effects, and it is not yet known if it will effectively control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age and Life Expectancy: Aged ≥18 and ≤75 years, with a life expectancy of ≥3 months, regardless of gender. 2. Diagnosis and History: Patients with histologically confirmed head and neck squamous cell carcinoma meeting the following conditions: 1. Primary tumor site located in the oral cavity, oropharynx, larynx, or hypopharynx. 2. History of prior radical or adjuvant radiotherapy with local/regional recurrence (confirmed by MRI/PET-CT). 3. The interval between the completion of the last radiotherapy and recurrence is ≥6 months (to ensure partial recovery of normal tissues). 3. 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. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 5. Organ and Marrow Function: Adequate organ and bone marrow function, defined as follows: 1. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥80×10⁹/L; Hemoglobin ≥8 g/dL. 2. 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. 3. Albumin: Serum Albumin ≥2.8 g/dL. 4. Renal Function: Serum Creatinine (Cr) ≤1.5×ULN OR Creatinine Clearance (CrCl) \>60 mL/min. 5. Coagulation: International Normalized Ratio (INR) ≤1.5; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. 6. 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. Exclusion Criteria: 1. Metastatic Disease: Presence of distant metastasis (Stage M1). 2. Prior Therapy: Receipt of any of the following treatments: 1. Prior treatment with HDAC inhibitors (e.g., chidamide, vorinostat), etc. 2. Major surgery or severe trauma within 4 weeks prior to the first dose. 3. 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). 4. Prior Toxicity: Occurrence of Grade ≥3 radiation necrosis or myelosuppression following the initial radiotherapy. 5. Medical Comorbidities: Presence of severe medical illnesses, such as: 1. Cardiac insufficiency Class II or higher (NYHA criteria); 2. Ischemic heart disease (e.g., myocardial infarction or angina pectoris); 3. Clinically significant supraventricular or ventricular arrhythmias; 4. Left Ventricular Ejection Fraction (LVEF) \<50% as determined by echocardiogram; 5. QTc interval \>450 msec for males or \>470 msec for females; 6. Abnormal Electrocardiogram(ECG) findings that the Investigator considers to pose an additional risk for the investigational drug. 6. 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). 7. Psychiatric Disorders: Any severe neurological or psychiatric illness that may prevent the patient from providing informed consent or complying with study procedures. 8. 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. 9. 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. 10. Investigator Discretion: Other factors determined by the Investigator that may affect the subject's ability to complete the study medication and follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, China
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Other studies related to the condition(s) this trial covers.
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- Vaccine trains immune system to fight HPV-Positive head and neck tumors
- New scan could sharpen detection of head and neck cancers
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