NCT07205536 Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy
| NCT ID | NCT07205536 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Myelosuppression |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07205536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Myelosuppression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07205536 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07205536 currently recruiting?
Yes, NCT07205536 is actively recruiting participants. Contact the research team at chenzhiming@ntu.edu.cn for enrollment information.
Where is the NCT07205536 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT07205536 clinical trial?
NCT07205536 is sponsored by Affiliated Hospital of Nantong University. The trial plans to enroll 30 participants.