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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
MyelosuppressionThoracic NeoplasmsChemoradiotherapy
Interventions
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.

DRUG

Oral 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.

Trial Locations (1)

226001

RECRUITING

Affiliated Hospital of Nantong University, Nantong

All Listed Sponsors
lead

Affiliated Hospital of Nantong University

OTHER

NCT07205536 - Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy | Biotech Hunter | Biotech Hunter