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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT04421469
Eligibility Criteria:
Inclusion Criteria:
1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases was defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥6months as judged by the Investigator;
3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
4. Adequate organ function;
5. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
6. Able and willing to provide signed informed consent form, and able to comply with all procedures.
7. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.
Exclusion Criteria:
1. Patients with a hypersensitivity to any of the drugs used in our study;
2. With any active autoimmune disease or history of autoimmune disease;
3. Clinically significant cardiovascular and cerebrovascular diseases;
4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
5. Active systemic infection;
6. Drug or alcohol abuse;
7. No or limited capacity for civil conduct;
8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；
10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and subject requiring hormone therapy during trials.
11. Pregnancy or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04421469
Study Brief:
Protocol Section:
NCT04421469