NCT06630780 Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT06630780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2029-12-31 |
Trial Parameters
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Brief Summary
To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.
Eligibility Criteria
Inclusion Criteria: * Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma * Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node \> 3cm or multiple positive cervical lymph nodes before surgery * The pathology of at least one cervical lymph node was determined by pCR； * Karnofsky's physical status score ≥70 points； * Age: 18 \~ 70 years old； * Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L * Patients participate voluntarily and sig