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

NCT07434063 | Recruiting

• 1 other identifier: HBAD-FN-ZLZH001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

• Incidence of FN

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

  From enrollment to the end of treatment 3 weeks later

Secondary Outcomes (1)

• The incidence of grade 3 and 4 neutropenia

  From enrollment to the end of treatment 6 weeks later

Study Arms (1)

Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors

Drug: Mecapegfilgrastim Injection

Interventions

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

Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• \. 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:
• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

HebeiMuFH

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

cheng doctor

CONTACT

18531117159; jiekejaker@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 42 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of radiotherapy department 1

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: February 25, 2026
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)