Status:
RECRUITING
Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Myelosuppression
Thoracic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 concurre...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07205536
Start Date
August 1 2025
End Date
December 1 2027
Last Update
December 11 2025
Active Locations (1)
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1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001