Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06492460
Eligibility Criteria:
Inclusion Criteria:
A. The pathological type is head and neck squamous cell carcinoma
* Stages III and IV
B. Radical surgery has been performed with high risk factors (one of below)
* extracapsular invasion of cervical metastatic lymph nodes
* positive incisional margin or inadequate incisional margin safety distance
C. No evidence of distant metastasis (M0).
D. Functional status: Karnofsky scale (KPS) \> 70.
E. Normal bone marrow function:
* white blood cell count \> 4×109/L
* hemoglobin \> 120g/L in males, 110g/L in females
* platelet count \> 100×109/L
G. Normal liver function:
* alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN)
* alkaline phosphatase (ALP) \< 2.5×ULN
* bilirubin \< ULN.
H. Normal renal function: creatinine clearance \> 60 ml/min.
I. Patients must be informed of the basic contents of this study and sign informed consent.
Exclusion Criteria:
A. Age \>70 years or \<18 years.
B. Treatment is palliative.
C. Previous chemotherapy (except induction chemotherapy prior to surgery).
D. Previous radiation therapy.
E. Women who are pregnant or breastfeeding
F. Previous history of malignant tumor.
G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
* unstable heart disease that requires treatment
* kidney disease
* chronic hepatitis
* poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
* mental illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06492460
Study Brief:
Protocol Section:
NCT06492460