Thiopegfilgrastim to prevent bone marrow suppression during chemoradiotherapy for esophageal or lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling adults with thoracic tumors who are planned for concurrent chemoradiotherapy and are at intermediate-to-high risk for febrile neutropenia. Participants are placed in Group 1 (monitoring with use of short-acting or oral leukocyte-stimulating agents such as Leucogen if neutrophils fall below 1.5×10^9/L) or Group 2 (single prophylactic subcutaneous sulfated PEGylated G-CSF injection 24 hours after chemotherapy at a fixed 6 mg dose or 100 μg/kg). Neutrophil counts, episodes of febrile neutropenia, treatment delays, and safety events are recorded during the first follow-up cycle. The protocol aims to generate evidence on whether a long-acting G-CSF approach reduces neutropenia and related complications compared with conventional supportive care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhiming CHEN
• Email: chenzhiming@ntu.edu.cn
• Phone: 86+15851396885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.