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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT05397769
Eligibility Criteria:
Inclusion Criteria:
* ECOG 0-1
* histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx
* stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients
* NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
* ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
* creatinine\<1.5×ULN
Exclusion Criteria:
* recurrent or metastatic NPC patients
* histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
* already received radiation or chemotherapy
* pregnant or lactating women, or women of childbearing age without birth control
* HIV (+)
* had other cancers before
* used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before
* complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose
* with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)
* use of massive dose of glucocorticoids within 4 weeks before enrollment
* laboratory test values do not meet relevant standards within 7 days before enrollment
* significantly lower functions of heart, liver, lung, kidney and bone marrow
* serious or uncontrolled medical diseases or infections
* participating other clinical trial in the same time
* HBsAg (+) and HBV DNA \>1×10E3 copiers /mL
* HCV (+) unless HCV RNA PCR(-)
* with any other treatment contraindications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05397769
Study Brief:
Protocol Section:
NCT05397769