Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chem… (NCT07205536) | Clinical Trial Compass
RecruitingPhase 2
Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
China30 participantsStarted 2025-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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