Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chem… (NCT07205536) | Clinical Trial Compass
RecruitingPhase 2
Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
China30 participantsStarted 2025-08-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.