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Experimental combo aims to tackle returning head and neck cancer

NCT ID NCT07545967

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

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