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Enrolling by invitationNCT07829276Updated Sep 18, 2026

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years to 75 Years
Sex
All
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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.

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Conditions studied

  • Malignant Tumor

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.).

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chun'an First People's Hospital
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What researchers measure

Primary outcomes

  1. FN incidence rate

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Grade III-IV bone marrow suppression rate

    Time frame: From enrollment to the end of treatment at 8 weeks

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Study locations

1 site
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07829276
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 18, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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