Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.

Eligibility criteria

Qualifiers

Age ≥18 and ≤75 years on the date of signing the informed consent form, male or female.

Histologically and imaging-confirmed T3-4a or N+M0 stage III-IVb (AJCC 8th) HNSCC, patients have received 2-courses of platinum-based chemotherapy and tirilizumab immunotherapy, and whose efficacy is assessed as Stable Disease (SD).

Life expectancy is at least 3 months.

ECOG PS 0-1。

Disqualifiers

Hypersensitivity to any of the antineoplastic therapeutic drug components of this research.

Those who have previously suffered from other malignant tumours and have received radiotherapy.

have uncontrolled clinical symptoms or cardiac disease including, but not limited to, symptomatic congestive heart failure (Grade 2 and above as determined by the New York Heart Association's Functional Class), unstable angina pectoris, acute myocardial ischaemia, and poorly controlled cardiac arrhythmias. Past history of myocarditis and cardiomyopathy.

Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, glucocorticoids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.

Trial design

Treatments tested in this trial

  • SBRT

Treatment groups

20 Participants
are divided into 1 treatment group