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

NCT07829276 | Enrolling By Invitation DMC

• 1 other identifier: KY2025220
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (1)

• FN incidence rate

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Grade III-IV bone marrow suppression rate

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Chun'an First People's Hospital

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.).

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

CN (1)