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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT05292027
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily participate and sign the informed consent form of the study in writing
2. Age 18-70 years old, regardless of gender
3. Pathological biopsy confirmed nasopharyngeal squamous cell carcinoma
4. Initial treatment
5. There are lesions that can be measured according to RECIST standard
6. KPS score ≥ 80
7. Estimated survival ≥ 6 months
8. The urine pregnancy test was negative (female), and contraceptive measures were taken from the test period to 3 months after the end of the test
9. Sufficient hematopoietic function: WBC ≥ 4 × 109/L，Hb≥100g/L，PLT≥100 × 109/L
10. Liver function: ALAT / ASAT \< 1.5 times of ULN, bilirubin \< 1.5 × ULN
11. Renal function: serum creatinine \< 1.5 × ULN
12. No distant metastasis
13. Lymph nodes meet one of them:node necrosis, extranodal invasion, or shortest diameter ≥3 cm
14. The clinical stage was N2-3 (AJCC / UICC 8th Edition) locally advanced nasopharyngeal carcinoma
15. According to the judgment of the researcher, the patient is considered to be able to comply with the protocol.
Exclusion Criteria:
1. There is evidence of distant metastasis
2. The primary tumor or lymph node has been treated surgically (except biopsy)
3. Patients with primary focus or lymph nodes who have received radiotherapy
4. Those who have received epidermal growth factor targeted therapy
5. The primary focus has received chemotherapy or immunotherapy
6. Other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ)
7. Subjects who have received other drug trials in recent 1 month
8. Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period
9. Have a serious history of allergy or special constitution
10. A history of severe lung or heart disease or serious complications, such as uncontrollable hypertension and heart failure
11. Refusal or inability to sign informed consent to participate in the trial
12. Drug or alcohol addicts
13. Having personality or mental illness, no civil capacity or limited civil capacity
14. Creatinine clearance \< 30ml / min
15. Active systemic infection
16. At the same time, they received chronic systemic immunotherapy or hormone therapy other than this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05292027
Study Brief:
Protocol Section:
NCT05292027