Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mecapegfilgrastim Injection.
- Who it may be relevant to
- Registry conditions: Neutropenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of FN [Time frame: From enrollment to the end of treatment 3 weeks later]
Secondary outcome measures (1)
- The incidence of grade 3 and 4 neutropenia [Time frame: From enrollment to the end of treatment 6 weeks later]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- HebeiMuFH — Shijiazhuang
Identifiers
NCT: NCT07434063 · HBAD-FN-ZLZH001