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, we 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Deep Learning; Head & Neck Squamous Cell Carcinoma

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 571

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510000
    • 510000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Postoperative concurrent chemoradiotherapy group; For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative concurrent chemoradiotherapy. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions over a treatment course of 6-7 weeks. Chemotherapy consisted of either cisplatin monotherapy (75 mg/m², once every 3 weeks) or a combination of cisplatin and 5-fluorouracil (cisplatin 75 mg/m², 5-fluorouracil 750 mg/m², once every 3 weeks), administered concurrently with radiotherapy.
Postoperative radiotherapy group; For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative radiotherapy alone. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions, over a total treatment course of 6-7 weeks.
Postoperative observation group; For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received no postoperative adjuvant therapy and were only followed up regularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year progress-free survival	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year overall survival	From the initiation of treatment to the date of death from any cause or the cutoff date of follow-up.	2 years
2-year recurrence-free survival	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.	2 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Collaborators: Peking University Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Deep Learning; Head & neck squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: NFEC-2025-364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No