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.
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。
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.
Single group
SBRT
RadiationPatient will receive SBRT (8Gy\*3F) in combination with the original regimen of neoadjuvant immunochemotherapy in course 3. Gross tumor target volume (GTV) based on the primary foci clearly identified by clinical and imaging examinations. The GTV was discharged 3 mm to generate a Planning target volume (PTV). the target area (PTV) was dosed accordingly to the PTV.
Objective response rate
Proportion of subjects containing complete response and partial response, i.e., the sum of the diameters of the target lesions is at least 30% smaller compared to baseline, derived from the RECIST v1.1 criteria at 3 weeks after the 3rd course of Neoadjuvant immunochemotherapy + SBRT, including by imaging assessment.
Overall response rate
The percentage of patients with a best overall response of CR or PR relative to the efficacy evaluable population.
Pathological complete response
No surviving tumor cells are found in a sample of a completely resected tumor.
Major pathologic response
Percentage of residual viable tumor cells ≤10% in samples of completely resected tumors.
Pathological partial response
Percentage of residual viable tumor cells \>10%, ≤70% in samples of completely resected tumors.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
