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Enrolling by invitation Observational

Study on the Efficacy and Safety of Different Doses of PEG-rhG-CSF for Primary Prevention of Febrile Neutropenia

NCT07829276 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-11-01
Last updated
2026-09-18

Condition(s) studied

Malignant Tumor

Study summary

In a prospective, multicenter, real-world setting, the efficacy and safety of 3mg low-dose pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in the primary prevention of febrile neutropenia (FN) after chemotherapy in cancer patients were verified to address the two major clinical pain points of current fixed 6mg dose, namely economic burden and adverse reactions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age at least 18 years; 2) Confirmed diagnosis of malignant tumor through histopathology or cytological analysis; 3) Eligible for chemotherapy and capable of tolerating multiple cycles of treatment; 4) Complete medical records and a Karnofsky Performance Status (KPS) score of ≥70; 5) Normal bone marrow function (ANC ≥ 1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥75 g/L, white blood cells ≥3.0×10⁹/L); 6) Use of PEG-rhG-CSF for primary prophylaxis, administered preventively during the first cycle and subsequent cycles of chemotherapy; 7) Agreement to use effective contraception during the study period and for 6 months after discontinuation; and 8) Willingness to participate. Exclusion Criteria: (1) Blood routine, liver and kidney function, and electrocardiogram test results indicate contraindications for chemotherapy; (2) History of chemotherapy or radiotherapy within the past six months; (3) Prior treatment with PEG-rhG-CSF or rhG-CSF; (4) Concurrent uncontrolled infectious diseases; (5) Concurrent coagulation dysfunction; (6) Long-term alcohol or psychoactive drug dependence; (7) Tumor with bone marrow metastasis or bone marrow invasion; (8) History of hematopoietic stem cell transplantation; (9) Concurrent immune system disorders; (10) Pregnancy and lactation.

Primary outcome measure(s)

  • FN incidence rate — From enrollment to the end of treatment at 8 weeks

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Provincial People's Hospital Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07829276 on ClinicalTrials.gov ↗ ← All trials in China