Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Recruiting now · Not applicable

Conditions studied: Head and Neck Squamous Cell Carcinoma (HNSCC)

In brief

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.

Key facts

Study ID

NCT06630780

Run by

Sun Yat-sen University

People needed

50

Starts

2024-09-26

Expected to finish

2029-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 sign informed consent forms.

You may not qualify if…

• Previous head and neck radiation treatment
• Severe complications；
• Pregnant or lactating women
• Who were deemed unsuitable for inclusion by the researchers.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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