Malignant TumorNCT07829276
Study on the Efficacy and Safety of Different Doses of PEG-rhG-CSF for Primary Prevention of Febrile Neutropenia
An observational study of Malignant Tumor, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumor
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Real-world Study on the Efficacy and Safety of Low-dose PEGylated Recombinant Human Granulocyte Colony-stimulating Factor (PEG rhG CSF) in Primary Prevention of Febrile Neutropenia (FN) in Cancer Patients After Chemotherapy
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chun'an First People's Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FN incidence rate
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Grade III-IV bone marrow suppression rate
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829276
- Sponsor's protocol ID
- KY2025220
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Real-world Study on the Efficacy and Safety of Low-dose PEGylated Recombinant Human Granulocyte Colony-stimulating Factor (PEG rhG CSF) in Primary Prevention of Febrile Neutropenia (FN) in Cancer Patients After Chemotherapy
- ClinicalTrials.gov ID
- NCT07829276
- Acronym / sponsor ID
- KY2025220
- Conditions
- Malignant Tumor
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chun'an First People's Hospital | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FN incidence rate
Time frame: From enrollment to the end of treatment at 8 weeks
1 secondary outcome
Grade III-IV bone marrow suppression rate
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FN incidence rate (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.