Neutropenia
Conditions
Brief 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.
Interventions
Use it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time
Sponsors
Hebei Medical University Fourth Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of FN | From enrollment to the end of treatment 3 weeks later | The incidence of neutropenic fever (FN) in the first cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 3 and 4 neutropenia | From enrollment to the end of treatment 6 weeks later | The incidence of grade 3 and 4 neutropenia |
Countries
China
Contacts
CONTACTcheng doctor
Outcome results
None listed