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

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.

Eligibility

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

Conditions4

Interventions2

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