RecruitingNCT07434063

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


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

200 participants

Start Date

Jun 18, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • \. 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 Criteria1

  • \. 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.

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Interventions

DRUGMecapegfilgrastim Injection

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


Locations(1)

HebeiMuFH

Shijiazhuang, Hebei, China

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NCT07434063


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