Preventing neutropenia after cancer treatment with mecapegfilgrastim injections

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

This will try mecapegfilgrastim injections to prevent low white blood cell counts (neutropenia) in adults with solid tumors getting chemotherapy, radiotherapy, or immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT07434063 on ClinicalTrials.gov

What this trial studies

This multicenter, observational real-world study follows adults with solid tumors who receive mecapegfilgrastim injections as prophylaxis against neutropenia after cancer treatment. Clinicians give mecapegfilgrastim for primary or secondary prevention when patients are judged to be at high or increased risk of febrile neutropenia or have had prior neutropenic events. The study collects safety and effectiveness data—such as rates of neutropenia, febrile neutropenia, treatment delays, and adverse events—without changing routine clinical care. Data are gathered at participating sites, primarily Hebei Medical University Fourth Hospital, to reflect everyday clinical practice.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed solid malignant tumors who will receive chemo, radiotherapy, or immunotherapy and are judged to be at high or increased risk for febrile neutropenia or have prior neutropenic/dose-limiting events are ideal candidates.

Not a fit: Patients allergic to mecapegfilgrastim, pregnant or breastfeeding individuals, those unable to cooperate due to mental/neurological disorders, or patients not at risk for treatment-induced neutropenia are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could reduce the incidence of neutropenia and related treatment delays or infections in cancer patients undergoing therapy.

How similar studies have performed: Pegylated G-CSF agents like pegfilgrastim have a strong evidence base showing reduced neutropenia and febrile neutropenia, while real-world data specifically for mecapegfilgrastim are more limited.

Eligibility criteria

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.

Where this trial is running

Shijiazhuang, Hebei

• HebeiMuFH — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: cheng doctor

Conditions Neutropenia