Last updated: January 26, 2024
Sponsor: Wuxi People's Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Metastatic Cancer
Treatment
Granulocyte infusion
Clinical Study ID
NCT06240767
WX03-02B0205-072100-62
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 ~ 75 years old (inclusive), gender is not limited
- Malignant tumor confirmed by puncture pathology/postoperative pathology, or PET-CTmulti-focal high signal, clinical stage IV
- Physical status score of 0-2 in ECOG scale
- Expected survival time ≥3 months
- Have measurable lesions, calculate the sum of the longest diameter of all targetlesions, and report as the baseline sum diameter: the lesions can be accuratelymeasured in at least one direction (record the longest diameter), as long as itconforms to RECIST1.1; If there are multiple lesions, a maximum of 5 lesions (no morethan 2 per organ) are required; The efficacy of hematological malignancies such asleukemia can be confirmed by cytology/histology
- more than 4 weeks have elapsed since previous drug therapy, radiation therapy andsurgery; Oral fluorouracil and small molecule targeted drugs required for more than 2weeks or within 5 half-lives of the drug (whichever is longer)
- Laboratory tests meet the following criteria: (1) Bone marrow function: absolute countof blood neutrophils (ANC) ≥110^9/L, platelets (PLT) ≥7510^9/L; (2) Liver function:serum total bilirubin (STB), bound bilirubin (CB) ≤ upper limit of normal (ULN) 1.5,alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN2.5 (in theabsence of liver metastasis), or ≤ULN5 (in the presence of liver metastasis); (3)Kidney function: serum creatinine (Cr) ≤ULN1.5, endogenous creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula)
- Anti-neutrophil antibody test results are negative
- The patient volunteered and signed the informed consent
Exclusion
Exclusion Criteria:
- 1: Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, suchas arrhythmia within 30 days, congestive heart failure, or severe coronary arterydisease 2: HIV infection, no recent (within 30 days) use of immunosuppressive drugs other thansteroids 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 testpositive 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
Study Design
Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Granulocyte infusion
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Wuxi People's Hospital
Wuxi, Jiangsu 214043
ChinaActive - Recruiting
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