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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02902432
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed unrespectable or postoperative recurrent squamous cell carcinoma of the head and neck;
* No prior radiation or chemotherapy and biotherapy before;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Life expectancy greater than 3 months;
* Patients must have adequate bone marrow function:
* Platelets ≥ 80×109/L
* Hemoglobin ≥100 g/L
* Absolute NeutrophilCount ≥1.5×109/L
* white blood cell≥ 3.5×109/L
* Patients must have adequate liver and renal function:
* Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 × upper limit of normal
* Alkaline phosphatase \< 2.5 × upper limit of normal
* Total bilirubin \< 1.5 mg/dL
* Creatinine \<1.5 mg/dL× upper limit of normal
* A cardiac ejection fraction \> 50%;
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Participation in any investigational drug study within 4 weeks preceding the start of study treatment;
* Age ≤18 or ≥75 years of Age;
* Pregnant or breastfeeding women;
* Serious, uncontrolled, concurrent infection(s) requiring antibiotics;
* Clinically apparent central nervous system metastases or carcinomatous meningitis;
* Treatment for other carcinomas within the last 3 months;
* Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory;
* Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02902432
Study Brief:
Protocol Section:
NCT02902432