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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03117257
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent
2. Age 18-70 years old, gender is not limited
3. histologically proved to be squamous cell carcinoma
4. No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.
After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients
5. Karnofsky score ≥70
6. Survival is expected to be ≥ 6 months
7. Women of childbearing age should be guaranteed contraception during the study period
8. (WBC) ≥4 × 109 / L \* (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L \* (unit normal value)
9. liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) \<upper limit of normal (ULN) 1.5 times; total bilirubin \<1.5 × ULN
10. renal function: serum creatinine \<1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
11. no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
12. The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).
Exclusion Criteria:
1. There is a distant shift
2. primary lesions or lymph nodes were radiotherapy
3. had received epidermal growth factor targeted therapy
4. primary tumor had received chemotherapy or immunotherapy
5. had other malignancies (except for cured basal cell carcinoma or cervical cancer)
6. pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
7. have a serious history of allergies or specific physical
8. Abuse of drugs or alcohol addicts
9. Person who has personality or mental illness, no civil capacity or limited civil capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03117257
Study Brief:
Protocol Section:
NCT03117257