Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy (ANC-IIT-004)

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 2

Conditions: Thoracic Neoplasms; Myelosuppression; Chemoradiotherapy

Treatments: Drug: Oral or short-acting granulocyte-stimulating agents; Drug: Mecapegfilgrastim injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07205536

2024-K299-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Oral or short-acting granulocyte-stimulating agents

Active Comparator group

Description:

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.

Treatment:

Drug: Oral or short-acting granulocyte-stimulating agents

Mecapegfilgrastim injection

Experimental group

Description:

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.

Treatment:

Drug: Mecapegfilgrastim injection