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RECRUITINGNA

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT06630780•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Detailed Description

In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 sign informed consent forms.

Exclusion Criteria

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

January 26, 2024

Primary Completion Date

December 31, 2029

Completion Date

December 31, 2029

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Head and Neck Cancers

RADIATION

Contacts

Chun-Yan Chen

CONTACT

020-87342926 chenchuny@sysucc.org.cn

Ya-Ni Zhang

CONTACT

020-87342926 zhangyn1@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

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