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

RecruitingPhase 2Ages 18 Years - 75 YearsAllAffiliated Hospital of Nantong University
NCT07205536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Signed informed consent; willing and able to comply with protocol-mandated visits * The patient is indicated for concurrent chemoradiotherapy and is currently/receiving or will receive a high-risk chemotherapy regimen for febrile neutropenia (FN risk ≥20%), or is currently/receiving or will receive an intermediate-risk chemotherapy regimen for FN (FN risk 10%\~20%) with additional FN risk factors. Exclusion Criteria: * 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
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What it tests

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

1 site
Affiliated Hospital of Nantong University
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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