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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT04766359
Eligibility Criteria:
Inclusion Criteria:
* Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
* The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
* Initial treatment patients who have not received anti-tumor therapy;
* No history of other malignant tumors;
* Male or female, aged 18 to 70 years old;
* Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
* Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
* No serious heart, lung, liver, kidney and other important organ dysfunction;
* Karnofsky score ≥70 points;
* Sign the informed consent form;
* Able to follow research protocols and follow-up procedures.
Exclusion Criteria:
* Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
* Find distant metastases before treatment;
* Women who are pregnant or breastfeeding;
* Disagree to sign the informed consent form;
* Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
* Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
* Known to be allergic to possible chemotherapy drugs;
* Patients with other malignant tumors;
* Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
* Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
* Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN;
* Any uncertain factors that affect patient safety or compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04766359
Study Brief:
Protocol Section:
NCT04766359