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

A Clinical Study on the Safety and Efficacy of Mecapegfilgrastim in Preventing Myelosuppression Induced by Concurrent Chemoradiotherapy for Thoracic Malignancies

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.

Group 1: Monitor the changes in neutrophil levels during the first follow-up cycle after enrollment in this study. When the neutrophil level falls below 1.5×10⁹/L, the investigator will communicate with the patient to determine whether to use conventional leukocyte-increasing drugs such as Licorice tablets. If so, the patient will be assigned to Group 1.

Group 2: After enrollment in this study, the investigator will communicate with the patient to determine whether to use Sulfated PEG-Interferon injection to prevent and treat neutropenia. If so, 24 hours after the end of the chemotherapy cycle, the patient will receive a subcutaneous injection of Sulfated PEG-Interferon once. The recommended dose is a fixed dose of 6 mg per injection; or, based on the patient's weight, an individualized treatment dose of 100 μg/kg. The patient will then be assigned to Group 2.

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