An observational study in Malignant Tumor, sponsored by Zhejiang Provincial People's Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Zhejiang Provincial People's Hospital · Observational
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.
This project is a multicenter, prospective, non randomized, three cohort observational study based on the real world. Obtain approval from the hospital ethics review committee before conducting the research. According to the inclusion and exclusion criteria, it is expected to include 350 malignant tumor patients aged 18 years or older who will receive treatment between January 2026 and December 2027. The team leader unit plans to have 300 people, and the sub center plans to have 50 people. The patient is undergoing chemotherapy for the first time, and the chemotherapy regimen is high-risk for FN. All patients signed an informed consent form, requiring the attending physician to clearly inform them that the CSCO guidelines recommend prevention for high-risk patients, but respect the patient's right to choose, and also record the reasons for the patient's choice (economic factors, concerns about adverse reactions, etc.).
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.
FN incidence rate
Time frame: From enrollment to the end of treatment at 8 weeks
Grade III-IV bone marrow suppression rate
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: Undecided
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Zhejiang Provincial People's Hospital