About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
For subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors, the researchers believe that primary/secondary prevention of thiapegfegostine injection is required after tumor treatment
Trial design
Case-only
Prospective
Treatments tested in this trial
Mecapegfilgrastim Injection
DrugUse it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time
Treatment groups
Trial outcomes
Primary outcomes
Incidence of FN
The incidence of neutropenic fever (FN) in the first cycle
Secondary outcomes
The incidence of grade 3 and 4 neutropenia
The incidence of grade 3 and 4 neutropenia
Sponsors and contacts
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