Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
Recruiting now · Phase 2
Conditions studied: Myelosuppression, Thoracic Neoplasms, Chemoradiotherapy
In brief
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.
Key facts
- Study ID
- NCT07205536
- Run by
- Affiliated Hospital of Nantong University
- People needed
- 30
- Starts
- 2025-08-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-12-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Signed informed consent; willing and able to comply with protocol-mandated visits
- The patient is indicated for concurrent chemoradiotherapy and is currently/receiving or will receive a high-risk chemotherapy regimen for febrile neutropenia (FN risk ≥20%), or is currently/receiving or will receive an intermediate-risk chemotherapy regimen for FN (FN risk 10%\~20%) with additional FN risk factors.
You may not qualify if…
- 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
Where it is running
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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