Safety and Efficacy Study of Mecapegfilgrastim to Prevent Myelosuppression from Concurrent Chemoradiotherapy in Thoracic Tumor Patients

What this Trial Is About

Researchers are evaluating the safety and effectiveness of mecapegfilgrastim in treating moderate-to-severe myelosuppression caused by concurrent chemoradiotherapy in patients with thoracic tumors such as esophageal or lung cancer. This observational study aims to provide strong evidence to support the use of long-acting granulocyte-stimulating agents for patients undergoing this combined treatment. The research is sponsored by the Affiliated Hospital of Nantong University and is a Phase 2 clinical trial. Participants are divided into two groups based on their neutrophil levels and treatment plans. In one group, neutrophil counts are monitored, and if levels fall below 1.5×10⁹/L, standard granulocyte-boosting drugs like leucogen tablets may be used. The other group receives a single subcutaneous injection of mecapegfilgrastim 24 hours after each chemotherapy cycle, with a fixed dose of 6 mg or a weight-based dose of 100 µg/kg. Rescue therapy with short-acting granulocyte colony-stimulating factors (G-CSF) can be given if neutrophil counts remain critically low. During the study, patients will have their neutrophil and other blood toxicity levels checked at specific time points, including days 7 and 14, and after radiotherapy completion. Researchers will track the incidence of hematologic and non-hematologic toxicities to assess treatment effects. The study involves regular follow-ups, blood tests, and clinical evaluations, with participation lasting through chemotherapy and radiotherapy cycles up to the study end in 2027.

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