Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection

ConditionNeutropenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Mecapegfilgrastim Injection

    Drug

    Use it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors1 intervention

Trial outcomes

Primary outcomes

1

Incidence of FN

The incidence of neutropenic fever (FN) in the first cycle

Time frame
From enrollment to the end of treatment 3 weeks later

Secondary outcomes

1

The incidence of grade 3 and 4 neutropenia

The incidence of grade 3 and 4 neutropenia

Time frame
From enrollment to the end of treatment 6 weeks later

Other outcomes

Sponsors and contacts

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