Actively Recruiting
Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
Led by Hebei Medical University Fourth Hospital · Updated on 2026-02-25
200
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter observational real-world study to observe and evaluate the use of Mecapegfilgrastim Injection in patients with solid malignant tumors. The study focuses on assessing the efficacy and safety of this injection to prevent neutropenia in tumor patients undergoing radiotherapy, chemotherapy, or immunotherapy. Participants are those who require such treatments and are considered by researchers to need Mecapegfilgrastim for primary or secondary prevention of neutropenia. Participants will receive Mecapegfilgrastim Injection at a fixed dose of 6 mg or 100 µg/kg 24 hours after the end of each treatment cycle. The study monitors these patients during their routine tumor treatment to collect real-world data on the prevention of neutropenia. There are no placebo or comparator groups since this is an observational study. During the study, researchers will track the incidence of febrile neutropenia (FN) from enrollment until three weeks after the end of treatment, as well as the incidence of grade 3 and 4 neutropenia up to six weeks after treatment. Participants will be observed for treatment outcomes and safety, with data collected from their regular medical care visits. The total duration of participation varies based on their treatment timelines.
CONDITIONS
Brief Title
Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with malignant tumors confirmed by histopathology or cytology
- Age 18 years or older
- Currently receiving treatment regimens with high febrile neutropenia risk, or moderate risk with additional risk factors
- History of febrile neutropenia or dose-limiting neutropenia in previous treatment cycles
- Researchers believe the medication regimens will cause neutropenia affecting treatment
- Researchers believe the patient can benefit from the study medication
- Participants voluntarily agree and can sign informed consent
You will not qualify if you...
- Allergy to the study drug Mecapegfilgrastim Injection
- Mental or neurological disorders preventing cooperation
- Pregnant or lactating women, or women of childbearing age refusing contraception
- Patients considered unsuitable for inclusion by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks after enrollment
Participants receive Mecapegfilgrastim Injection 24 hours after each treatment cycle to prevent neutropenia.
Visits aligned with treatment cycles over the 6-week period
Trial Site Locations
Total: 1 location
1
HebeiMuFH
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
C
cheng doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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