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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04388033
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years; Male or Female.
2. Treatment-naïve patients after Resection of Glioblastoma.
3. Histologically confirmed Glioblastoma.
4. KPS ≥ 60
5. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
6. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
7. Patients must be able to understand the investigational nature of the study and provide informed consent.
Exclusion Criteria:
1. Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
2. Those with severe autoimmune diseases or immunodeficiency diseases.
3. Those who are expected to take systemic corticosteroids within three months.
4. Those who needs long-term usage of immunosuppressive agents.
5. Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
6. Those who plan to receive any other anti-tumor treatment during the trial.
7. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
8. Patients with other malignant tumors.
9. Those with active infections, etc.
10. Suspected or confirmed a history of alcohol and drug abuse.
11. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
12. Women who are pregnant or nursing.
13. Women of childbearing age who refuse to contraception.
14. Active participation in another clinical treatment trials.
15. According to the judgment of the investigator, other conditions that the plan cannot be followed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04388033
Study Brief:
Protocol Section:
NCT04388033