De-Escalation Surgery After Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
De-escalation surgery: Surgical planning and resection will be conducted based on tumor boundaries assessed after neoadjuvant therapy.
Standard Surgery: Surgical planning and resection will be conducted based on tumor boundaries assessed prior to neoadjuvant therapy.
radiotherapy: Radiotherapy is recommended within 6 weeks after surgery. Patients achieving a pathological complete response (pCR) may be exempted. For the primary tumor and involved nodes, 60-70 Gy in 30-35 fractions is delivered once daily, Monday to Friday (low risk: 60 Gy; high risk: 66 Gy; residual disease: 70 Gy). Suspected subclinical areas receive 45-50 Gy (2 Gy/f) or 54-63 Gy (1.6-1.8 Gy/f). Concurrent cisplatin is given when extracapsular nodal extension or positive/close margins (\<1 mm) are present: 100 mg/m² every 3 weeks ×3, with renal function-based dose adjustment. For patients unsuitable for cisplatin, cetuximab is administered at 400 mg/m² in the first week, then 250 mg/m² weekly.
adjuvant immunotherapy: Postoperative adjuvant immunotherapy was administered in accordance with the initial treatment plan and clinical indications.
Study summary
This is a multicenter, randomized, open-label, non-inferiority clinical trial designed to evaluate whether downgraded surgery-guided by post-immunotherapy tumor boundaries-can achieve comparable 3-year overall survival (OS) to standard surgery in patients with Stage III-IVa locally advanced head and neck squamous cell carcinoma (HNSCC) who have responded to neoadjuvant immunotherapy. A total of 356 patients will be randomized 1:1 to receive either downgraded or standard surgery, followed by risk-adapted adjuvant therapy. The primary endpoint is 3-year OS, with secondary endpoints including disease-free survival, quality of life, complication rates, and cost-effectiveness. The study hypothesizes that downgraded surgery will preserve organ function and quality of life without compromising survival outcomes.
Eligibility
Primary outcome measure(s)
- 3-year overall survival (OS) rate — 3 years
The proportion of subjects in the intention-to-treat population who are alive at 3 years after randomization.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Ninth Peolple's Hospital | Shanghai | Shanghai Municipality |
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07320690 on ClinicalTrials.gov ↗ ← All trials in China