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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06240767
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 \~ 75 years old (inclusive), gender is not limited
2. Malignant tumor confirmed by puncture pathology/postoperative pathology, or PET-CT multi-focal high signal, clinical stage IV
3. Physical status score of 0-2 in ECOG scale
4. Expected survival time ≥3 months
5. Have measurable lesions, calculate the sum of the longest diameter of all target lesions, and report as the baseline sum diameter: the lesions can be accurately measured in at least one direction (record the longest diameter), as long as it conforms to RECIST1.1; If there are multiple lesions, a maximum of 5 lesions (no more than 2 per organ) are required; The efficacy of hematological malignancies such as leukemia can be confirmed by cytology/histology
6. more than 4 weeks have elapsed since previous drug therapy, radiation therapy and surgery; Oral fluorouracil and small molecule targeted drugs required for more than 2 weeks or within 5 half-lives of the drug (whichever is longer)
7. Laboratory tests meet the following criteria: (1) Bone marrow function: absolute count of blood neutrophils (ANC) ≥1\*10\^9/L, platelets (PLT) ≥75\*10\^9/L; (2) Liver function: serum total bilirubin (STB), bound bilirubin (CB) ≤ upper limit of normal (ULN) \*1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5 (in the absence of liver metastasis), or ≤ULN\*5 (in the presence of liver metastasis); (3) Kidney function: serum creatinine (Cr) ≤ULN\*1.5, endogenous creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula)
8. Anti-neutrophil antibody test results are negative
9. The patient volunteered and signed the informed consent
Exclusion Criteria:
* 1: Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, such as arrhythmia within 30 days, congestive heart failure, or severe coronary artery disease
2: HIV infection, no recent (within 30 days) use of immunosuppressive drugs other than steroids
3: Pregnant and lactating women
4: Previous history of stem cell and organ transplantation
5: Patients who have been using or are using immunosuppressants for a long time
6: Symptomatic brain metastases are not controlled
7: People who are known to be severely allergic to granulocyte infusion (or test positive for anti-neutrophil antibodies)
8: People with coagulation disorders
9: Mental disorders are not under control
10: Patients with severe autoimmune diseases
11: Cases deemed unsuitable for inclusion by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06240767
Study Brief:
Protocol Section:
NCT06240767