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

NCT ID: NCT07205536

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

Group 1: Monitor the changes in neutrophil levels during the first follow-up cycle after enrollment in this study. When the neutrophil level falls below 1.5×10⁹/L, the investigator will communicate with the patient to determine whether to use conventional leukocyte-increasing drugs such as Licorice tablets. If so, the patient will be assigned to Group 1.

Group 2: After enrollment in this study, the investigator will communicate with the patient to determine whether to use Sulfated PEG-Interferon injection to prevent and treat neutropenia. If so, 24 hours after the end of the chemotherapy cycle, the patient will receive a subcutaneous injection of Sulfated PEG-Interferon once. The recommended dose is a fixed dose of 6 mg per injection; or, based on the patient's weight, an individualized treatment dose of 100 μg/kg. The patient will then be assigned to Group 2.

Conditions

Myelosuppression; Thoracic Neoplasms; Chemoradiotherapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral or short-acting granulocyte-stimulating agents

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.

Group Type: ACTIVE_COMPARATOR

Oral or short-acting granulocyte-stimulating agents

Intervention Type: 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.

Mecapegfilgrastim injection

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.

Group Type: EXPERIMENTAL

Mecapegfilgrastim injection

Intervention Type: 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.

Interventions

Oral or short-acting granulocyte-stimulating agents

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.

Intervention Type: DRUG

Mecapegfilgrastim injection

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiming CHEN

Role: CONTACT

chenzhiming@ntu.edu.cn

86+15851396885

Facility Contacts

Zhiming Chen

Role: primary

86+15851396885

Other Identifiers

2024-K299-01

Identifier Type: -

Identifier Source: org_study_id