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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT07110558
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 Years to 70 Years;
2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. TNM stage based on AJCC 9th edition with N0-1 (retroperitoneal lymph nodes only), and either one following criteria:
1. T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;
2. T3-4;
5. Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion).
6. Male and no pregnant female
7. Normal bone marrow function: white blood cell count \> 4×10\^9/L, hemoglobin \> 90g/L, platelet count \> 100×10\^9/L;
8. Normal liver function: total bilirubin (TBIL) \< upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) \< 1.5 × ULN;
9. Normal kidney function: creatinine clearance rate ≥ 60 ml/min;
10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
Exclusion Criteria:
1. Patients have evidence of relapse or distant metastasis
2. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
3. Patients with positive cervical lymph nodes
4. Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).
5. Receiving radiotherapy or chemotherapy previously
6. Patients with active immunodeficiency disease and history of immunodeficiency disease
7. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS)
8. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible.
9. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved.
10. HBV DNA \>2000 cps/ml (or HBV DNA \> 2000 IU/ml); or HCV RNA \>1000 cps/ml; Hepatitis B surface antigen (HBsAg) positive and HCV antibody positive.
11. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
12. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
13. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.
14. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
15. Severe, uncontrolled medical conditions and infections.
16. At the same time using other test drugs or in other clinical trials.
17. Refusal or inability to sign informed consent to participate in the trial.
18. Other treatment contraindications.
19. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07110558
Study Brief:
Protocol Section:
NCT07110558