Head and Neck Squamous Cell Carcinoma HNSCCPhase 1NCT07545967
Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
A Phase 1 study testing Chidamide and radiotherapy in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Chidamide and radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2026to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Xingchen Peng, 18980606753, pxx2014@163.com
About this study
Official title: A Prospective, Single-arm Clinical Study on Re-irradiation Combined With Chidamide in the Treatment of Patients With Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
Read the detailed description
The aim of this clinical trial is to systematically evaluate the safety and tolerability of combining the Histone Deacetylase(HDAC) inhibitor chidamide with salvage re-irradiation (re-RT), and to explore its preliminary anti-tumor activity in adults with recurrent squamous cell carcinoma of the head and neck (HNSCC) at West China Hospital of Sichuan University. Specifically, it aims to determine the incidence of Dose-Limiting Toxicity (DLT) during the dose-escalation phase.
Participants will undergo a 6-week course of intensity-modulated radiation therapy (IMRT) combined with chidamide, utilizing a 3+3 dose-escalation design. The regimen consists of chidamide (20 mg or 30 mg orally twice weekly, with an interval of at least 3 days between doses) plus fixed-dose IMRT (60 Gy in 30 fractions of 2 Gy each, administered once daily, 5 days a week). Participants will also undergo protocol-specified safety monitoring, with adverse events graded according to CTCAE v5.0, alongside routine clinical evaluations and laboratory tests. Finally, safety follow-up and long-term monitoring for disease status and survival outcomes will be conducted as defined by the protocol.
- Being tested
- Chidamide, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Dose Escalation Design:
Chidamide will be administered orally according to the protocol-specified schedule(20mg BIW).
Administration Schedule:
Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration).
The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy.
ChidamideDrug
Dose Escalation Design:
Chidamide will be administered orally according to the protocol-specified schedule(30mg BIW).
Administration Schedule:
Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration).
The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy.
radiotherapyRadiation
All subjects receive fixed-dose Intensity-Modulated Radiation Therapy (IMRT): 60 Gy in 30 fractions (2 Gy per fraction), administered once daily, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| chidamide (Dose Level 1) + re-RT | Experimental | In this cohort, chidamide 20 mg BIW will be administered in combination with radiotherapy. The entire treatment course lasted approximately 6 weeks. Receives: Drug: Chidamide; Radiation: radiotherapy |
| chidamide (Dose Level 2) + re-RT | Experimental | In this cohort, chidamide 30 mg BIW will be administered in combination with radiotherapy. The entire treatment course lasted approximately 6 weeks. Receives: Drug: Chidamide; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
To evaluate the incidence of DLT associated with the combination of salvage re-irradiation and chidamide during the dose-escalation phase in patients with recurrent HNSCC following prior radiotherapy, in order to determine the Recommended Dose for Expansion (RDE).
Measured: From the first dose of chidamide to 30 days after the completion of radiotherapy.
Secondary outcomes (3)
Objective Response Rate (ORR)
Defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) following treatment with salvage re-irradiation and chidamide, based on tumor burden changes assessed by imaging (CT/MRI).
Measured: From the start of treatment to 3 months after the completion of radiotherapy.
Progression-Free Survival (PFS)
Defined as the time from the start of salvage re-irradiation and chidamide treatment to the first disease progression or death from any cause.
Measured: From the date of treatment initiation to the date of first documented progression or death from any cause, whichever occurs first, assessed for up to 1 year.
Overall Survival (OS)
Defined as the time from the start of salvage re-irradiation and chidamide treatment to death from any cause.
Measured: From the date of treatment initiation to the date of death from any cause, assessed for up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start23 Apr 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545967
- Sponsor's protocol ID
- 2026-361
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study on Re-irradiation Combined With Chidamide in the Treatment of Patients With Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy
- ClinicalTrials.gov ID
- NCT07545967
- Acronym / sponsor ID
- 2026-361
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.
Detailed description
The aim of this clinical trial is to systematically evaluate the safety and tolerability of combining the Histone Deacetylase(HDAC) inhibitor chidamide with salvage re-irradiation (re-RT), and to explore its preliminary anti-tumor activity in adults with recurrent squamous cell carcinoma of the head and neck (HNSCC) at West China Hospital of Sichuan University. Specifically, it aims to determine the incidence of Dose-Limiting Toxicity (DLT) during the dose-escalation phase.
Participants will undergo a 6-week course of intensity-modulated radiation therapy (IMRT) combined with chidamide, utilizing a 3+3 dose-escalation design. The regimen consists of chidamide (20 mg or 30 mg orally twice weekly, with an interval of at least 3 days between doses) plus fixed-dose IMRT (60 Gy in 30 fractions of 2 Gy each, administered once daily, 5 days a week). Participants will also undergo protocol-specified safety monitoring, with adverse events graded according to CTCAE v5.0, alongside routine clinical evaluations and laboratory tests. Finally, safety follow-up and long-term monitoring for disease status and survival outcomes will be conducted as defined by the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chidamide (Dose Level 1) + re-RT | Experimental | Drug: Chidamide, Radiation: radiotherapyIn this cohort, chidamide 20 mg BIW will be administered in combination with radiotherapy. The entire treatment course lasted approximately 6 weeks. |
| chidamide (Dose Level 2) + re-RT | Experimental | Drug: Chidamide, Radiation: radiotherapyIn this cohort, chidamide 30 mg BIW will be administered in combination with radiotherapy. The entire treatment course lasted approximately 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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:
Key exclusion criteria (18 listed)
- Metastatic Disease: Presence of distant metastasis (Stage M1).
- Prior Therapy: Receipt of any of the following treatments:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideDose Escalation Design: Chidamide will be administered orally according to the protocol-specified schedule(20mg BIW). Administration Schedule: Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration). The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy. | Drug | chidamide (Dose Level 1) + re-RT |
| ChidamideDose Escalation Design: Chidamide will be administered orally according to the protocol-specified schedule(30mg BIW). Administration Schedule: Chidamide treatment initiates 1 week prior to the start of re-irradiation(to achieve steady-state plasma concentration). The interval between doses is no less than 3 days. Administration time is 30 minutes after breakfast, continuing until the completion of radiotherapy. | Drug | chidamide (Dose Level 2) + re-RT |
| radiotherapyAll subjects receive fixed-dose Intensity-Modulated Radiation Therapy (IMRT): 60 Gy in 30 fractions (2 Gy per fraction), administered once daily, 5 days a week. | Radiation | chidamide (Dose Level 1) + re-RT, chidamide (Dose Level 2) + re-RT |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: From the first dose of chidamide to 30 days after the completion of radiotherapy.
To evaluate the incidence of DLT associated with the combination of salvage re-irradiation and chidamide during the dose-escalation phase in patients with recurrent HNSCC following prior radiotherapy, in order to determine the Recommended Dose for Expansion (RDE).
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: From the start of treatment to 3 months after the completion of radiotherapy.
Progression-Free Survival (PFS)
Time frame: From the date of treatment initiation to the date of first documented progression or death from any cause, whichever occurs first, assessed for up to 1 year.
Overall Survival (OS)
Time frame: From the date of treatment initiation to the date of death from any cause, assessed for up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingchen Peng principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chidamide and radiotherapy in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: From the first dose of chidamide to 30 days after the completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.