RecruitingPhase 2NCT07205536

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


Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mecapegfilgrastim injection and a drug called Oral or short-acting granulocyte-stimulating agents for people with chemoradiotherapy, myelosuppression, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMecapegfilgrastim 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.

DRUGOral or short-acting granulocyte-stimulating agents

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.


Locations(1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT07205536


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