Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant
This is a single-center, open-label, randomized, controlled, exploratory clinical trial designed to evaluate the efficacy and safety of de-escalated surgery compared with standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who achieved a partial response (PR) o
| Condition(s) | Locally Advanced Head and Neck Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a single-center, open-label, randomized, controlled, exploratory clinical trial designed to evaluate the efficacy and safety of de-escalated surgery compared with standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who achieved a partial response (PR) or complete response (CR) after neoadjuvant immunochemotherapy. Eligible patients will be randomly assigned in a 1:1 ratio to either the de-escalated surgery group (experimental) or the standard surgery group (control). The de-escalated surgery group will undergo limited tumor resection and selective neck dissection based on clinical and imaging response, while preserving important anatomical structures and functions when feasible. The control group will receive standard surgi |
| Who can participate | Inclusion Criteria: * Patients diagnosed with stage III-IVa head and neck squamous cell carcinoma (HNSCC) according to the AJCC 8th edition TNM staging system, who have achieved a partial response (PR) or complete response (CR) after receiving neoadjuvant immunochemotherapy consisting of a PD-1 inhibitor in combination with nab-paclitaxel and carboplatin/cisplatin. * No prior history of other malignant tumors. * Aged between 18 and 75 years. * Normal baseline (preoperative) clinical and laboratory findings: * 1.Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L without the use of granulocyte colony-stimulating factor (G-CSF) within the previous 14 days * 2.Platelet count ≥ 100 × 10⁹/L without blood transfusion within the previous 14 days * 3.Hemoglobin \> 9 g/dL without blood transfusion or ery |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Qunxing Li,MD |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2026-01-12 |
| NCT ID | NCT07369882 |
| Official listing | https://clinicaltrials.gov/study/NCT07369882 |