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.
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
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
Parallel
Mecapegfilgrastim injection
DrugAfter enrollment, a single subcutaneous dose of mecapegfilgrastim should be administered 24 hours following completion of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or an individualized 100 μg/kg based on the patient's body weight. If neutrophil counts remain below 0.5 × 10⁹/L for more than 24 hours after mecapegfilgrastim administration, short-acting G-CSF may be used as rescue therapy at the investigator's discretion until neutrophil levels return to normal.
Oral or short-acting granulocyte-stimulating agents
DrugIn the first cycle after enrollment, patients will be followed for changes in neutrophil counts. Should the neutrophil level fall below 1.5 × 10⁹/L, the investigator may, based on clinical judgment, decide whether to intervene with leucogen tablets or other granulocyte-boosting agents. If the count remains below 1.0 × 10⁹/L, short-acting G-CSF may be administered as a rescue therapy.
Incidence of hematologic toxicity
Hematologic toxicity, assessed by CBC performed 1 day before chemotherapy and on days 7 and 14 post-chemotherapy; CBC may be done at an external facility.
The incidence of non-hematologic toxicity
Secondary Outcome Measures: Non-hematologic toxicity On Day 1 of cycles 1 and 2: vital signs, complete blood count, urinalysis, stool routine, serum chemistry, coagulation panel, and 12-lead ECG. On Days 7 and 14 of cycles 1 and 2: repeat complete blood count only. All patient-reported adverse events are captured through 30 days after completion of radiotherapy.
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