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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT06780592
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-65 years, female or male
2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
3. c-MET overexpression diagnosed by IHC
4. KPS ≥60
5. Adequate hematological, renal, and hepatic function.
All patients should meet the following criteria:
1. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
2. serum creatinine clearance ≥80 mL/min
3. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
4. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT \< 2.5 × ULN
6. The patient and his/her family members were informed and provided signed and informed consent
Exclusion Criteria:
1. Any previous postoperative treatment except for concurrent chemoradiotherapy;
2. Individuals unable to undergo cranial MRI examination;
3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;
4. Uncontrolled hypertension;
5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \>1000IU/ml;
7. Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
8. Pregnant or lactating women;
9. Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
10. Individuals deemed unsuitable for participation in this clinical trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06780592
Study Brief:
Protocol Section:
NCT06780592