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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT04393506
Eligibility Criteria:
Inclusion Criteria:
* Eastern cooperative oncology group performance status (ECOG PS) score: 0-2 points
* Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
* Clinical stage of III/IVA (AJCC 2018)
* Blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/L, platelets\> 80,000/mm3
* Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal
* Renal function: serum creatinine \<1.5 times the upper limit of normal
* Sign the informed consent
Exclusion Criteria:
* There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
* Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, heart disease of grade 2 or higher diagnosed according to the classification criteria of the New York Heart Association (NYHA) 3 months before enrollment\]
* Active severe clinical infection (\> CTCAE 5.0 version 2 infection)
* Difficult to control hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 90 mmHg) or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
* Women during pregnancy or lactation
* Participated in other clinical studies within 30 days before enrollment
* Other circumstances that the investigator thinks are not suitable for participating in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04393506
Study Brief:
Protocol Section:
NCT04393506