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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT06279767
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 65, no gender restrictions.
2. Histologically confirmed glioblastoma as the primary tumor after surgery.
3. Patients with recurrent glioblastoma confirmed by MRI after standard treatment (surgery, Stupp regimen) failure, supported by RANO criteria evaluation.
4. At least one measurable intracranial tumor lesion according to RANO criteria.
5. No prior treatment with 6-mercaptopurine or similar drugs.
6. General condition assessed by Karnofsky Performance Status (KPS) score ≥ 60.
7. Normal bone marrow function: white blood cell count ≥ 3.5 × 10\^9/L, neutrophil count ≥ 2.0 × 10\^9/L, hemoglobin count ≥ 90 g/L, platelet count ≥ 80 × 10\^9/L.
8. Normal organ functions such as heart and lung, and no severe internal diseases.
9. Willing to sign an informed consent form, good compliance, able to attend regular follow-ups, and voluntarily agree to comply with the study protocol.
Exclusion Criteria:
1. Participants who do not consent.
2. Vulnerable populations such as pregnant women, children, and adolescents.
3. No history of or concurrent malignancy within the past 5 years.
4. Abnormal liver function (total bilirubin \> 1.5 times the upper limit of normal, ALT/AST \> 2 times the upper limit of normal).
5. Impaired kidney function (serum creatinine \> 1.5 times the upper limit of normal).
6. Presence of organic heart disease leading to clinical symptoms or cardiac dysfunction (NYHA ≥ Grade 2).
7. Factors significantly affecting oral drug absorption, such as difficulty swallowing, intestinal obstruction, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06279767
Study Brief:
Protocol Section:
NCT06279767