Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection

February 24, 2026 updated by: Jun wang, Hebei Medical University Fourth Hospital
This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy/chemotherapy/immunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy/chemotherapy/immunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary/secondary prevention after receiving tumor treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • HebeiMuFH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors, the researchers believe that primary/secondary prevention of thiapegfegostine injection is required after tumor treatment

Description

Inclusion Criteria:

  • 1. Patients with malignant tumors confirmed by histopathology or cytology; 2. Age ≥18 years old; 3. After referring to various guidelines, the researchers believed that the subjects:

    1. Patients who are currently receiving treatment regimens with high FN risk;
    2. Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;
    3. FN or dose-limiting neutropenia events have occurred in previous treatment cycles;
    4. In addition to the above, the researchers believe that the medication regimens will cause neutropenia and affect the normal treatment of the subjects; 4. Researchers believe that they can benefit; 5. Voluntarily participate in this clinical trial and be able to sign the informed consent form in person.

Exclusion Criteria:

  • 1. Those who are allergic to the test drug； 2. Those with mental or neurological disorders who are unable to cooperate； 3. Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures； 4. Those who were considered unsuitable for inclusion by the researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors
Drug: Mecapegfilgrastim Injection
Use it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of FN
Time Frame: From enrollment to the end of treatment 3 weeks later
The incidence of neutropenic fever (FN) in the first cycle
From enrollment to the end of treatment 3 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of grade 3 and 4 neutropenia
Time Frame: From enrollment to the end of treatment 6 weeks later
The incidence of grade 3 and 4 neutropenia
From enrollment to the end of treatment 6 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 5, 2025

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBAD-FN-ZLZH001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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