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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT04921995
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
2. Not suitable for surgery;
3. Clinical stage rT3-4N0-2 (rII-IVa, AJCC/UICC 8th);or residual disease afer surgery.
4. ECOG score 0-1;
5. No prior treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
6. No contraindications to immunotherapy or chemoradiotherapy;
7. Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
8. Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
9. Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
10. Take effective contraceptions during and two months after treatment;
11. Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
1. Have local necrosis in recurrent lesions, estimated with bleeding risk;
2. Unexplained fever \> 38.5 ℃, except for tumor fever;
3. Treated with ≥ 5 days antibiotics one month before enrollment;
4. Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
5. Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
6. Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
8. Have known allergy to large molecule protein products or any compound of study therapy;
9. Pregnant or breastfeeding;
10. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
11. Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
90 Years
Study:
NCT04921995
Study Brief:
Protocol Section:
NCT04921995