Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAffiliated Hospital of Nantong University

About this trial

This is a prospective observational study designed to observe and evaluate the safety and efficacy of mecapegfilgrastim in the treatment of moderate-to-severe myelosuppression associated with concurrent chemoradiotherapy. The project will provide more robust evidence-based medical support for the use of long-acting granulocyte-stimulating agents in patients undergoing concurrent chemoradiotherapy.

Eligibility criteria

Qualifiers

Aged 18-75 years at the time of giving informed consent, both sexes eligible

Histologically or cytologically confirmed thoracic tumor (esophageal or lung cancer)

Investigator judges the patient suitable for treatment with mecapegfilgrastim injection or leucogen tablets

Expected survival > 3 months

Disqualifiers

Pregnant or lactating women

Known hypersensitivity to mecapegfilgrastim, pegylated or non-pegylated rhG-CSF, or any E. coli-derived product

Any severe comorbidity that, in the investigator's opinion, compromises patient safety or ability to complete the study

Any other condition that, in the investigator's judgment, could interfere with study conduct or interpretation of results

Trial design

Treatments tested in this trial

  • Mecapegfilgrastim injection
  • Oral or short-acting granulocyte-stimulating agents

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
Affiliated Hospital of Nantong University226001, NantongJiangsu, China

Sponsors and collaborators

Affiliated Hospital of Nantong University

Lead sponsor