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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT04124666
Eligibility Criteria:
Inclusion Criteria for Subjects:
* Malignant tumor confirmed by puncture pathology/postoperative pathology;
* Clinical stage IV;
* Performance status of ≤2 on the ECOG scale
* Life expectancy of at least 3 months
* All patients was diagnosed metastatic tumor by histology and cytology. Cytoreductive surgery can be performed if the patient can endure surgery.
* Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter recorded) as 20 mm with conventional technique or as 10 mm with spiral CT scan.If the lesion is between 15mm and 20mm, the thickness of the CT layer should be no more than 0.5mm. For multiple lesions, select a representative 10 lesions (maximum 5 in the same organ) and calculate the sum of the longest diameters of all target lesions as the baseline sum diameter.
* ≥ 4 weeks since prior medical therapy, radiation therapy, and surgery
* Laboratory tests meet the following criteria:
A. Bone marrow function: Absolute blood neutrophil (ANC) count ≥1\*10\^9 /L, blood small (PLT) ≥75\*10\^9 /L.
B. Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper limit of normal (ULN) \* 1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN\*2.5 (in the absence of liver metastases), or ≤ULN\*5 (with liver metastases);
C. Renal function: serum creatinine (Cr) ≤ ULN \* 1.5, endogenous creatinine clearance (Ccr) ≥ 50 mL / min (calculated using the Cockcroft-Gault formula, see Appendix 2);
* The anti-neutrophil antibody test result was negative.
* The patient volunteered and signed an informed consent form.
Exclusion Criteria of Subjects:
* Arrhythmia, congestive heart failure, or severe coronary artery disease;
* Pregnant or nursing women;
* Patients with severe autoimmune diseases;
* Patients who have been using or are using immunosuppressive agents for a long time;
* Those with coagulopathy;
* Cases that the investigator considered inappropriate for inclusion.
Inclusion Criteria for Granulocyte Donors:
* Must have signed Donor-participant Informed Consent Form
* Must be able to provide granulocytes in local blood donation center, and transport collected granulocytes to the hospital blood bank or clinical application within 24 hours;
* Must score \>80% in Cancer Killing Assay (CKA), a score of 60-80% would be considered when there are insufficient donors;
* Must have CMV negative or positive sero-testing completed; only seronegative donors are accepted for a seronegative recipient;
* Must have compatible ABO and RH typing with the recipient;
* Must be qualified for blood donation: aged 18-35, male \>50kg or female \>45kg, normal cardiopulmonary function, specific gravity of blood male≥1.052 or female≥1.051, HbsAg, anti-HCV, anti-HIV, or syphilis tests.
Exclusion Criteria for Granulocyte Donors:
* Dental or other minor surgery within preceding 15 days;
* Arrhythmia, congestive heart failure, or severe coronary artery disease;
* Major surgery within preceding 6 months;
* Appendectomy, hernia repair, or tonsillectomy within preceding 3 months;
* Females 3 days before or after menstruation, ≤6 months since prior pregnancy or abortion, ≤ 1 year since delivery/breastfeeding;
* Recovery from flu or acute gastroenteritis within preceding week, acute renal infection within preceding month, pneumonia within preceding 3 months;
* Recovery from infectious diseases such as dysentery within preceding 6 months, typhoid fever within preceding year, brucellosis within preceding 2 years, or malaria within preceding 3 years;
* Recovery from localized dermatitis within preceding week, extensive inflammation within preceding 2 weeks;
* Receiving whole blood or blood components within preceding 5 years;
* Allergic to G-CSF mobilizer.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04124666
Study Brief:
Protocol Section:
NCT04124666