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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT05589961
Eligibility Criteria:
Inclusion Criteria:
* The pathological result of glioblastoma WHO grade 4;
* Received standard TMZ chemotherapy and radiotherapy;
* It is not suitable to undergo surgical resection of the lesion again or other drug treatment, or the patient refuses other treatment;
* Men and women aged 18-75;
* Disease progression was confirmed by CT or MRI examination within 4 weeks before enrollment;
* KPS score ≥70;
* Expected survival time ≥ 3 months, and can meet the follow-up requirements;
* Within 7 days before the start of treatment, the results of routine blood tests, liver and renal function tests, and hemagglutination laboratory tests meet the following criteria:
Leukocyte (WBC) ≥ 3.0×109/L
Platelets (PLT) ≥ 100×109/L
Neutrophil (ANC) ≥ 1.5×109/L
Hemoglobin (HGB) ≥ 90g/L
Serum albumin ≥2.8g/dL
Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN) (\< 5×ULN for liver metastases)
Alanine aminotransferase (ALT) ≤2.5×ULN (≤5×ULN for liver metastases)
Total bilirubin (TIBC) ≤1.5×ULN, patients with liver cancer or liver metastases should ≤2×ULN
Serum creatinine (CR)≤1.5×ULN or creatinine clearance ≥50ml/min
AST and ALT levels ≤ 2.5×ULN, and patients with liver metastases or liver cancer should ≤ 5×ULN
International Normalized ratio (INR) ≤ 1.5
Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN
* Pregnancy should be ruled out for fertile women, and HCG tests for early pregnancy must be negative; Both male and female participants should ensure that they use contraception during the study and continue to use contraception until the end of the follow-up period;
* Volunteer to participate in the clinical study, cooperate with the doctor to carry out the study, and sign the informed consent form.
Exclusion Criteria:
* Participating in another clinical trial;
* Recurrence within 4 weeks after surgery;
* Recurrence within 4 weeks after chemotherapy;
* Recurrence within 4 weeks after radiotherapy;
* Increased intracranial pressure: midline shift ≥5mm, clinically significant visual edema, vomiting and nausea, or poor level of consciousness;
* Have active infection that is not controlled with appropriate anti-infective therapy;
* Patients with mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., cannot comply with the requirements of research treatment and monitoring;
* Organ transplants;
* Pregnant or lactating women; Persons with disabilities (blind, deaf, dumb, mentally disabled, physically disabled) or suffering from mental diseases as prescribed by law; Drug users or patients with a history of adverse drug abuse and alcohol dependence within 5 years;
* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as a positive hepatitis B surface antigen \[HBsAg\] test, HBV-DNA ≥ 500 IU/ml and abnormal liver function; Hepatitis C, defined as hepatitis C antibody \[HCV-AB\] positive, HCV-RNA above the detection limit of the assay, and abnormal liver function) or co-infection with hepatitis B and C;
* Any other factors that the investigator deems inappropriate for the subject to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05589961
Study Brief:
Protocol Section:
NCT05589961