Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Curative-Intent Treatment Cohort:None
Recurrent/Metastatic Treatment Cohort:None
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Pathological Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma. 2 Disease and Treatment Context: Newly Diagnosed Patients: Clinical stage qualifies for guideline-recommended radical therapy, with planned radical surgery, radiotherapy, or concurrent chemoradiotherapy; Recurrent/Metastatic Patients: Radiologically confirmed measurable lesions (according to RECIST 1.1), scheduled for systemic therapy (chemotherapy, immunotherapy, targeted therapy, etc.) or palliative radiotherapy. 3 Prognosis and Performance Status: Karnofsky Performance Status (KPS) >=70; ECOG performance status 0–2; life expectancy >=6 months. 4 Imaging and Sample Requirements: Imaging data available for tumor volume measurement (including primary gross tumor volume [GTV] and nodal gross tumor volume [GTVnd]) and radiomics analysis; Consent to undergo follow-up imaging examinations according to the protocol-defined time points.
Exclusion criteria
Exclusion criteria: 1 History of or concurrent other malignancies that have not been cured. 2 Previous or recent treatments that may interfere: Received systemic anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, etc.) within 4 weeks before enrollment; Received radiotherapy within 2 weeks before enrollment, which may affect baseline ctDNA or imaging measurements. 3 Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be enrolled if normalized with hormone replacement therapy)); Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled, whereas patients with asthma requiring medical intervention with bronchodilators are excluded. 4 Uncontrolled cardiovascular diseases: Myocardial ischemia or myocardial infarction of grade II or higher, poorly controlled arrhythmia (including QTc interval >= 470 ms); Cardiac insufficiency of NYHA class III–IV, or left ventricular ejection fraction (LVEF) 38.5°C during the screening period or before the first dose (investigator-judged fever due to tumor may be allowed for enrollment). 6 Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA >= 104 copies/ml) or hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay). 7 Women who are pregnant or breastfeeding. 8 In the investigator’s judgment, the subject has other factors that may lead to premature termination of the study, such as other serious diseases (including mental illness) requiring concomitant treatment, severely abnormal laboratory values, family or social factors, or any condition that may affect subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Distant Metastasis Free Survival;Locoregional Control Rate;Treatment-Related Adverse Event;The integrated predictive value of ctDNA combined with radiomics;The concordance between ctDNA and the pathological mutation; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Hospital of China Medical University
Outcome results
None listed