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New treatment option for Myelosuppression
Official title Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
ClinicalTrials.gov ID: NCT07205536
What this study is testing
What is Mecapegfilgrastim injection?
Mecapegfilgrastim injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelosuppression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.