Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Loc… (NCT06722495) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
China20 participantsStarted 2024-12-24
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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。
. Haematological analysis： 5.1 Absolute neutrophil count (ANC) ≥1.5×10\^9/L without granulocyte colony-stimulating factor in the last 14 days； 5.2 Absolute T-lymphocyte value ≥ 0.5 times the lower limit of normal value； 5.3 Platelets ≥100×10\^9/L without transfusion or platelet-boosting drugs in the last 14 days； 5.4 Haemoglobin ≥90g/L without transfusion or erythropoietin use in the last 14 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: 3 weeks after the 3rd course of Neoadjuvant immunochemotherapy + SBRT, including by imaging assessment.
Trial details
NCT IDNCT06722495
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
.1 Creatinine clearance\* (Ccr) ≥60 mL/min; \*Ccr will be calculated using the Cockcroft-Gault formula: Ccr = (140-age) × body weight (kg) / \[0.818 (0.85 for males, 0.85 for females) × blood creatinine (SCr, umol/L) \] or Ccr = (140-age) × body weight (kg)/ \[72 × blood creatinine (SCr, mg/dL) \]; 6.2 Creatinine ≤ 1.5 × upper limit of normal (ULN)； 6.3 Routine urinalysis suggests urinary protein ≤ +; 6.4 Quantitative 24-hour urine protein \<1.0g.
. Liver function:
Exclusion criteria
. 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.
. History of (non-infectious) pneumonia requiring steroids or current pneumonia.
. Have active tuberculosis.
. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first dose or current clinically active interstitial lung disease.
. Active or uncontrolled infection requiring systemic therapy.