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

ConditionHead and Neck Squamous Cell Carcinoma HNSCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this trial

To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age and Life Expectancy: Aged ≥18 and ≤75 years, with a life expectancy of ≥3 months, regardless of gender.

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).

Disqualifiers

Metastatic Disease: Presence of distant metastasis (Stage M1).

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

    Drug

    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.

  • 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.

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: chidamide (Dose Level 1) + re-RTExperimental treatment 2 interventions
Group B: chidamide (Dose Level 2) + re-RTExperimental treatment 2 interventions

Trial outcomes

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).

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

Secondary outcomes

1

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).

Time frame
From the start of treatment to 3 months after the completion of radiotherapy.
2

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.

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.
3

Overall Survival (OS)

Defined as the time from the start of salvage re-irradiation and chidamide treatment to death from any cause.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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