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 | 2024-09-26 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-09-26 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Liu-Wei Tang
STUDY DIRECTOR
The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06630780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Head and Neck Squamous Cell Carcinoma (HNSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06630780 currently recruiting?
Yes, NCT06630780 is actively recruiting participants. Contact the research team at chenchuny@sysucc.org.cn for enrollment information.
Where is the NCT06630780 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06630780 clinical trial?
NCT06630780 is sponsored by Sun Yat-sen University. The principal investigator is Liu-Wei Tang at The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University. The trial plans to enroll 50 participants.