NCT06630780Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Sept 2024
- Start date
- 26 Sept 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Head and neck cancer
- NCT number
- NCT06630780
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 26 Sept 2024 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous head and neck radiation treatment
Other
- Severe complications；
- Pregnant or lactating women
- Who were deemed unsuitable for inclusion by the researchers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.