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:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT05299203
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
2. Age ≥ 18 years old, ≤ 80 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
4. Head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using intensity modulated radiotherapy.
5. Blood routine examination: hemoglobin ≥ 100g/L, platelet count ≥ 75×10\^9/L, white blood cell count ≥ 3.0×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L. Blood biochemistry: total bilirubin≤1.5 upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, serum creatinine ≤1.5 ULN or creatinine clearance rate \>=60ml/min.
6. Have signed informed consent form.
Exclusion Criteria:
1. Allergic to the components of Sapropterin dihydrochloride tablets or severe allergic constitution.
2. Poor compliance.
3. Pregnant or breastfeeding.
4. Any previous radiotherapy to the head and neck region.
5. Patients deemed unsuitable for the study by the investigator (concomitant with any other serious disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05299203
Study Brief:
Protocol Section:
NCT05299203