A Phase 2 interventional study of Mecapegfilgrastim injection and Oral or short-acting granulocyte-stimulating agents in Myelosuppression, Thoracic Neoplasms and Chemoradiotherapy, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Affiliated Hospital of Nantong University · Phase 2, Interventional, and Treatment
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.
109 studies on the registry are indexed under Thoracic Neoplasms; 32 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 80 interventional studies indexed under Thoracic Neoplasms.
Browse Thoracic Neoplasms studies →Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
When the neutrophil count falls below 1.5 × 10⁹/L, the investigator will discuss with the patient whether to initiate standard granulocyte-boosting therapy such as leucogen tablets.
Drug: Oral or short-acting granulocyte-stimulating agents
Administer a single subcutaneous injection of mecapegfilgrastim 24 hours after the end of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or individualised dosing at 100 μg/kg based on patient body weight.
Drug: Mecapegfilgrastim injection
After 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.
In 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.
Time frame: Day 7,Day 14
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.
Time frame: Day 1, Day 7, and Day 14 of the first and second anti-tumor treatment cycles, and Day 30 after the completion of radiotherapy.
Plan to share: Undecided
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Affiliated Hospital of Nantong University