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NCT Number: NCT07434063

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

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.

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Key information

Conditions

Neutropenia Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Patients who are currently receiving treatment regimens with high FN risk;
  • Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;
  • FN or dose-limiting neutropenia events have occurred in previous treatment cycles;
  • 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.

Treatment and study plan

Mecapegfilgrastim injection

Drug

Use it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

cheng doctor

CONTACT

[email protected]

18531117159

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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