Thiopegfilgrastim to prevent bone marrow suppression during chemoradiotherapy for esophageal or lung cancer
A Clinical Study on the Safety and Efficacy of Mecapegfilgrastim in Preventing Myelosuppression Induced by Concurrent Chemoradiotherapy for Thoracic Malignancies
This will try mecapegfilgrastim (a long-acting G-CSF) to prevent low neutrophil counts in adults with esophageal or lung cancer receiving concurrent chemoradiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT07205536 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically or cytologically confirmed esophageal or lung cancer who are planned for concurrent chemoradiotherapy and have intermediate-to-high risk for febrile neutropenia are appropriate candidates.
Not a fit: Pregnant or breastfeeding patients, those with known hypersensitivity to mecapegfilgrastim or other G-CSF products, or patients with severe comorbidities that make participation unsafe are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients may experience fewer episodes of severe neutropenia, fewer infections, and fewer chemotherapy delays.
How similar studies have performed: Long-acting pegylated G-CSFs (for example pegfilgrastim) have demonstrated benefit in reducing chemotherapy-induced neutropenia in many oncology settings, though specific evidence in concurrent thoracic chemoradiotherapy is more limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantong, Jiangsu
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhiming CHEN
- Email: chenzhiming@ntu.edu.cn
- Phone: 86+15851396885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.