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OpenTrials
Enrolling by Invitation

NCT Number: NCT07532928

A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data

Based on multimodal data, the investigators establish a dynamic deep learning model to conduct prognostic risk assessment for patients and recommend the 'most suitable' treatment/follow-up regimen after radical treatment, assisting clinicians in improving homogenized evaluation levels and achieving individualized precision therapy, thereby providing scientific evidence for the currently widely debated selection of postoperative adjuvant therapy in locally advanced head and neck squamous cell carcinoma patients.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiation Oncology, Nanfang Hospital, Southern Medical University

Guangzhou, 510000, China

About this study

This clinical study is an observational bidirectional study. A retrospective cohort is used to train the model for recurrent risk prediction and adjuvant treatment decision-making, while a prospective cohort serves as an external validation set to verify the model performance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years.
  • Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025.
  • Patients who either seek medical treatment after June 2022 or sought medical treatment before that but have not lost contact with the hospital for more than 1 year are required to sign the informed consent form voluntarily.
  • Newly diagnosed head and neck squamous cell carcinoma (HNSCC) confirmed by histopathology.
  • Locally advanced disease without distant metastasis.
  • Complete clinical data (including patient demographics, tumor characteristics, treatment details, and prognostic variables).
  • Availability of MRI, CT, or PET-CT images before and after radical treatment.

Exclusion criteria

  • History of or coexisting secondary malignancies.
  • Lack of definitive radical treatment.
  • Absence of baseline or follow-up imaging (MRI/CT/PET-CT).
  • Investigator-determined unsuitability for study participation.

Treatment and study plan

Primary outcomes

  1. 2-year progress-free survival

    Time frame: 2 years

    From the initiation of treatment to the date of tumor progression (including local recurrence, regional lymph node metastasis, and distant metastasis) or tumor-related death, whichever occurs first. If no progression event was observed by the cutoff date of follow-up, the last follow-up date was used.

Secondary outcomes

  1. 2-year overall survival

    Time frame: 2 years

    From the initiation of treatment to the date of death from any cause or the cutoff date of follow-up.

  2. 2-year recurrence-free survival

    Time frame: 2 years

    From the initiation of treatment to the date of first local tumor recurrence, regional lymph node metastasis, or tumor-related death, whichever occurs first. If no such event was observed by the cutoff date of follow-up, the last follow-up date was used.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Peking University Shenzhen Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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