Clinical trial · Observational
Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mecapegfilgrastim Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors
- interventionNames
- Drug: Mecapegfilgrastim Injection
Primary outcomes (1)
- measure
- Incidence of FN
- timeFrame
- From enrollment to the end of treatment 3 weeks later
- description
- The incidence of neutropenic fever (FN) in the first cycle
Secondary outcomes (1)
- measure
- The incidence of grade 3 and 4 neutropenia
- timeFrame
- From enrollment to the end of treatment 6 weeks later
- description
- The incidence of grade 3 and 4 neutropenia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available