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

NCT07545967 | Recruiting Phase 1

• 1 other identifier: 2026-361
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC

Outcome Measures

Primary Outcomes (1)

• 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).

  From the first dose of chidamide to 30 days after the completion of radiotherapy.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  From the start of treatment to 3 months after the completion of radiotherapy.

• Progression-Free Survival (PFS)

  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)

  From the date of treatment initiation to the date of death from any cause, assessed for up to 1 year.

Study Arms (2)

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.

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.

Drug: Chidamide; Radiation: radiotherapy

Interventions

Chidamide DRUG

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.

chidamide (Dose Level 1) + re-RT

radiotherapy RADIATION

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.

chidamide (Dose Level 1) + re-RT; chidamide (Dose Level 2) + re-RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)