Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy

NCT07205536 | Recruiting Phase 2

• 1 other identifier: 2024-K299-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelosuppression; Chemoradiotherapy; Thoracic Neoplasms

Keywords

Neutropenia; Febrile neutropenia

Outcome Measures

Primary Outcomes (1)

• Incidence of hematologic toxicity

  Hematologic toxicity, assessed by CBC performed 1 day before chemotherapy and on days 7 and 14 post-chemotherapy; CBC may be done at an external facility.

  Day 7,Day 14

Secondary Outcomes (1)

• The incidence of non-hematologic toxicity

  Day 1, Day 7, and Day 14 of the first and second anti-tumor treatment cycles, and Day 30 after the completion of radiotherapy.

Study Arms (2)

Oral or short-acting granulocyte-stimulating agents

ACTIVE COMPARATOR

When the neutrophil count falls below 1.5 × 10⁹/L, the investigator will discuss with the patient whether to initiate standard granulocyte-boosting therapy such as leucogen tablets.

Drug: Oral or short-acting granulocyte-stimulating agents

Mecapegfilgrastim injection

EXPERIMENTAL

Administer a single subcutaneous injection of mecapegfilgrastim 24 hours after the end of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or individualised dosing at 100 μg/kg based on patient body weight.

Drug: Mecapegfilgrastim injection

Interventions

Mecapegfilgrastim injection DRUG

After enrollment, a single subcutaneous dose of mecapegfilgrastim should be administered 24 hours following completion of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or an individualized 100 μg/kg based on the patient's body weight. If neutrophil counts remain below 0.5 × 10⁹/L for more than 24 hours after mecapegfilgrastim administration, short-acting G-CSF may be used as rescue therapy at the investigator's discretion until neutrophil levels return to normal.

Mecapegfilgrastim injection

Oral or short-acting granulocyte-stimulating agents DRUG

In the first cycle after enrollment, patients will be followed for changes in neutrophil counts. Should the neutrophil level fall below 1.5 × 10⁹/L, the investigator may, based on clinical judgment, decide whether to intervene with leucogen tablets or other granulocyte-boosting agents. If the count remains below 1.0 × 10⁹/L, short-acting G-CSF may be administered as a rescue therapy.

Oral or short-acting granulocyte-stimulating agents

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Thoracic Neoplasms; Neutropenia; Febrile Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Zhiming CHEN

CONTACT

86+15851396885; chenzhiming@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-08

Locations

CN (1)