Can a smaller dose of a white blood cell booster protect cancer patients just as well?

NCT ID NCT07829276

Prevention Sponsor: Zhejiang Provincial People's Hospital Source: ClinicalTrials.gov ↗

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying whether a lower 3mg dose of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) can prevent febrile neutropenia, a serious drop in infection-fighting white blood cells, in cancer patients after chemotherapy. The standard 6mg dose works but costs more and can cause side effects. This real-world study follows 350 adults with malignant tumors who receive the lower dose as a preventive measure. The main goal is to see how many patients develop febrile neutropenia, with secondary checks on severe bone marrow suppression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: a lower 3mg dose of pegylated recombinant human granulocyte colony-stimulating factor, a drug that boosts white blood cell production
What this could lead to: If the lower dose works, cancer patients could receive the same infection protection after chemotherapy at a lower cost and with fewer side effects.
What could go wrong: This is a real-world study, not a randomized controlled trial, so results may be harder to interpret. The lower dose might not prevent febrile neutropenia as well as the standard 6mg dose, and the findings may not apply to all cancer types or chemotherapy regimens.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.).

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a smaller dose of a white blood cell booster protect cancer patients just as well?

What the study statuses mean